Category: Pharmacy

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…)

For Immediate Release

August 28, 2018

Contact

Consumers

Kathryn Weingart
Vice President Quality & Regulatory Affairs
 1-704-939-4342

Announcement

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. This recall should be carried out to the retail level.

Risk Statement: Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, including babies or very young children. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date. (more…)

For Immediate Release

August 27, 2018

Contact

Consumers

 1-855-869-1081

Announcement

Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

August 27, 2018

Contact

Consumers

 1-866-298-2740
 recall@kingbio.com

Announcement

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible 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. To date, King Bio has not received any reports of illness or injury. King Bio is recalling the products listed on the website link below as a precautionary measure. (more…)

 

For Immediate Release

August 23, 2018

Contact

Consumers

Torrent Medical Information
Medinfo.Torrent@apcerls.com
 1-800-912-9561
Qualanex
 1-888-424-4340
 1-800- 505-9291

Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which 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 as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

August 22, 2018

Contact

Consumers

King Bio
  recall@kingbio.com
 866-298-2740

Announcement

King Bio is voluntarily recalling the below products to the consumer level.

A small percentage of our products produced between 08/01/2015 and 08/01/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below.

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. King Bio has not received reports of injury or illness to date. (more…)

For Immediate Release

August 17, 2018

Contact

Consumers

Torrent Medical Information
Medinfo.Torrent@apcerls.com
1-800-912-9561

Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which 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 as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

August 9, 2018

Contact

Consumers

Jonathan H. Olive
  recalls@wprx.com
 888-354-9939

Announcement

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

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

For Immediate Release

August 8, 2018

Contact

Consumers

Joan Sanger, Site Head of Quality
 386-239-8787

Announcement

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. THolly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

Risk Statement: Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or  immuno-compromised. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall. (more…)