Category: Pharmacy

For Immediate Release

November 20, 2018

Contact

Consumers

888-406-9305

Announcement

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength.  These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the U.S. between March 2017 and November 2018.  The recalled batches are as follows:

NDC Product Description Strength Size Lot Number Expiry
0378-1721-93 Amlodipine and Valsartan Tablets, USP 5mg/160mg Bottles of 30 3066051 3/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10mg/160mg Bottles of 30 3079500 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3061986 11/2018
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079709 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3077618 11/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079708 1/2020
0378-5813-77 Valsartan Tablets, USP 80mg Bottles of 90 3063782 1/2019
0378-5814-77 Valsartan Tablets, USP 160mg Bottles of 90 3071352 7/2019
0378-5807-93 Valsartan Tablets, USP 40mg Bottles of 30 3061169 11/2018
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3081499 3/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080009 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080010 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3079205 1/2020
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3084886 2/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3093804 12/2019

Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. (more…)

For Immediate Release

November 8, 2018

Contact

Consumers

Sandoz Inc.
 1-800-525-8747

Media

Novartis Media Relations
  media.relations@novartis.com
 +41 61 324 2200

Announcement

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

To date, Sandoz Inc. has not received any reports of adverse events related to this lot. (more…)

For Immediate Release

November 2, 2018

Contact

Consumers

Janssen
1-800-526-7736

Media

Andrew Wheatley
awheatle@its.jnj.com
+1 (609) 664-1797

Announcement

The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions

TITUSVILLE, NJ – Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM® does not include the appropriate instructions for the Veridate® dispenser.

The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the consumer could take the pills in the incorrect order (still receiving an effective dose) or could take an inactive “reminder” pill instead of an “active” pill which could lead to breakthrough bleeding or an unintended pregnancy.

ORTHO-NOVUM® 1/35 and ORTHO-NOVUM® 7/7/7 tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions. Women should continue to take the 21 “active” pills (with hormones) (peach for ORTHO-NOVUM® 1/35; white, light-peach and peach for ORTHO-NOVUM® 7/7/7) for three weeks, followed by the one week of green “reminder” pills (without hormones).

The three lots affected by this recall are:

Product Description NDC Number (carton) NDC Number (pouch) Lot No. Expiration Date
ORTHO-NOVUM® 1/35 50458-176-06 50458-176-28 18BM114 03/2020
ORTHO-NOVUM® 7/7/7 50458-178-06 50458-178-28 18CM120 03/2020
ORTHO-NOVUM® 7/7/7 50458-178-12 50458-178-12 18BM110 03/2020

This recall only affects the U.S., and no other ORTHO® contraceptive products beyond the three lots listed above are impacted by this recall action. ORTHO TRI-CYCLEN LO®, ORTHO TRI-CYCLEN®, ORTHO MICRONOR® and ORTHO CYCLEN® are not affected. (more…)

For Immediate Release

October 31, 2018

Contact

Consumers

800-428-4674

Media

Nicole Clark
Communications Business Partner
nicole.clark@roche.com
(515) 559-5770

Announcement

This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018.

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.

  • Patient Self-Testers (PST) will receive replacement test strips from their self-testing service providers.
  • Professional / Healthcare Providers will receive their replacement test strips through Roche.

The affected CoaguChek XS PT Test Strips are used with the following CoaguChek professional and patient self-testing point-of-care meters listed in the table below.

Healthcare Providers (professional) Patient Self-Testers
CoaguChek XS Professional CoaguChek XS PST
CoaguChek XS Pro CoaguChek Vantus
CoaguChek XS Plus

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to the most recent International Normalized Ratio (INR) Standard. Since calibrating to this new standard, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected lots of CoaguChek XS PT Test Strips listed in the table below.

Product

Catalog
numbers

Affected lot numbers

CoaguChek XS PT Test
2×24 Strips

04625315160

28124111
28124121
28631911
28631921
28631924
28632021
28632213
28632312
28632412
29415113
29415123
29494221
29494312
29494613
29494711
29778721
29779012
29779213
29779214
30497213
30497311
30497413

30497423
30497515
31404314
31404821
32264116
32264212
32264316
32264317
32264411
32264421
33045913
33046011
33046113
33046312
33046314
33046321
33046322
33449612
33449712
33449723
33449817

CoaguChek XS PT Test
6 Strips

04625374160

CoaguChek XS Test 24
Tests USA

07797826160

The lot number is printed on the test strip label, which is applied to the test strip vial.  See the picture below for an example of the location of the lot number on the test strip vial.

Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

The affected test strips in the table above will be replaced with new CoaguChek XS PT Test Strips, which are not impacted by the Urgent Medical Device Correction (UMDC) and can be used without the need for confirmatory measurements with a laboratory method.

Action Required – Patient Self-Testers:
Stop using and discard any CoaguChek XS PT Test Strips listed in the table above.  As of October 29, 2018, Roche started shipping newly calibrated test strips to healthcare providers and patient self-testing service providers. These test strips have been calibrated to the previous INR standard. For questions regarding when you will receive your new test strips, please contact your test strip provider. If you have any questions regarding your testing schedule, please contact your healthcare provider.

Action Required – Health Care Providers:
Stop using and discard any CoaguChek XS PT Test Strips listed in the table above. Also, please advise your self-testing patients to do the same (see above). Roche Diagnostics has started shipping unaffected test strips to healthcare providers, patient self-testing service providers and distribution partners. (more…)

For Immediate Release

October 30, 2018

Contact

Consumers

Westminster’s Regulatory Affairs
 888-354-9939
Golden State Medical Supply Incorporated
 (800) 284-8633 ext. 215

Media

Siva Reddy P.V
 (1)-855-724-3436

 

Announcement

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC)

To date, Sciegen Pharmaceuticals Inc has not received any reports of adverse events related to this product. (more…)

For Immediate Release

October 22, 2018

Contact

Consumers

Promise Pharmacy
 mark@promisepharmacy.com
 (727) 772-0500 x233

Announcement

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials,to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

To date Promise Pharmacy has not received any reports of adverse events related to this recall. Potential adverse health consequences could range from limited eye irritation, inflammation and visual impairment to permanent ocular damage with the use of this eye drop solution. (more…)

For Immediate Release

October 3, 2018

Contact

Consumers

 Nativeremedies@silverstarbrands.com
 1-888- 736-6389

Announcement

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with  lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals and animals. To date, Silver Star Brands, Inc. has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

September 28, 2018

Contact

Consumers

Inmar
  robaxin@inmar.com
 1-866-391-0620

Announcement

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” (see picture below for location of incorrect text).

Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

September 10, 2018

Contact

Consumers

Luis R DeLeon
Carlos Deleon
  713-790-1693

Announcement

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.  These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be non-sterile. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority. (more…)

For Immediate Release

September 5, 2018

Contact

Consumers

Stericycle Customer Service – Recalls
 Camber7719@stericycle.com
 1-888-548-8526
Med Line
 1-866-495-1995

 

Announcement

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg.

A consumer who inadvertently consumes Losartan may experience renal dysfunction, hyperkalemia, and hypotension. Hypotension (dizziness, fatigue) would be the most likely risk if Losartan was taken by an otherwise healthy patient (no concomitant conditions other than asthma or allergic rhinitis; no other concomitant medications). Losartan has a warning for fetal toxicity. There is risk of fetal morbidity and death if pregnant women unknowingly take Losartan instead of Montelukast. Camber Pharmaceuticals, Inc has not received any reports of adverse events related to this recall. (more…)