Category: Pharmacy

Summary

Company Announcement Date:
September 28, 2018
FDA Publish Date:
May 02, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Company Name:
Endo Pharmaceuticals
Brand Name:
Endo Pharmaceuticals
Product Description:
Robaxin® (methocarbamol tablets, USP) 750mg Tablets

FDA 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…)

Summary

Company Announcement Date:
April 30, 2019
FDA Publish Date:
April 30, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Lack of Sterility
Company Name:
Sagent Pharmaceuticals
Brand Name:
Sagent Pharmaceuticals
Product Description:
Ketorolac Tromethamine Injection

Company Announcement

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue. (more…)

Summary

Company Announcement Date:
April 29, 2019
FDA Publish Date:
April 29, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Product Defect
Company Name:
AmEx Pharmacy
Brand Name:
AmEx Pharmacy
Product Description:
Bevacizumab 1.25mg/0.05mL 31G Injectable

Company Announcement

AmEx Pharmacy is voluntarily recalling one Lot of Bevacizumab 1.25mg/0.05mL 31G Injectable to the consumer/user level. The Monoject Syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient.

The additional force needed to express the drug product could potentially result in damage to the eye while the needle is in the eye. To date, AmEx Pharmacy has received three reports associated with the Lot being recalled as either being difficult to express, two of which, resulted in an Adverse Drug Event. (more…)

Summary

Company Announcement Date:
April 29, 2019
FDA Publish Date:
April 29, 2019
Product Type:
Animal & Veterinary
Animal Drugs
Reason for Announcement:
Lack of Sterility
Company Name:
Norbrook Laboratories Limited
Brand Name:
Norbrook Laboratories Limited
Product Description:
Subcutaneous injectable drug products

Company Announcement

Norbrook Laboratories Limited of Newry, Northern Ireland is expanding the recall of subcutaneous injectable drug products that began in early March 2019. Norbrook is adding to the recall four lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and one lot of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs.

As initially reported in early March 2019, Norbrook Laboratories Limited discovered that product tested, released and distributed within the USA was manufactured on an aseptic line that subsequently did not pass process simulation tests. (more…)

Summary

Company Announcement Date:
April 26, 2019
FDA Publish Date:
April 26, 2019
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Company Name:
Teva Pharmaceuticals USA, Inc
Brand Name:
GSMS Incorporated
Product Description:
Losartan Potassium 25 mg and 100 mg Tablets USP

Company Announcement

Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets.

To date, Teva has not received any reports of adverse events related to the lots being recalled. (more…)

Summary

Company Announcement Date:
April 24, 2019
FDA Publish Date:
April 24, 2019
Product Type:
Animal & Veterinary
Animal Drugs
Reason for Announcement:
Company Name:
Jurox Incorporated
Brand Name:
Jurox
Product Description:
Alfaxan unpreserved, an intravenous injectable anaesthetic for cats and dogs

Company Announcement

Vial size Lot Number Distributed from Expiry
10mL #27787 April 2017 March 2020
10mL #25955 October 2016 August 2019

This recall has been initiated due to an out of specification result for clarity observed in the stability program.

The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel inflammation, and formation of blood clots or embolisms, which can be life threatening.

Jurox Incorporatedhas received two adverse event reports for lot #25955 and one adverse event report for lot #27787, involving five animals to date. Reasons for adverse event reporting included seizure, swelling of conjunctiva, respiratory arrest and a death. (more…)

Summary

Company Announcement Date:
April 24, 2019
FDA Publish Date:
April 24, 2019
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Company Name:
Legacy Pharmaceutical Packaging
Brand Name:
Legacy
Product Description:
Losartan Potassium USP

Company Announcement

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
April 21, 2019
FDA Publish Date:
April 21, 2019
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Company Name:
Alvogen
Brand Name:
Alvogen
Product Description:
Fentanyl Transdermal System

Company Announcement

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen Inc. has not received any reports of adverse events related to this issue. (more…)

Summary

Company Announcement Date:
March 25, 2019
FDA Publish Date:
April 27, 2019
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Company Name:
Legacy Pharmaceutical Packaging
Brand Name:
Legacy
Product Description:
Losartan Potassium USP

Company Announcement

Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
March 19, 2019
FDA Publish Date:
March 21, 2019
Product Type:
Drugs
Reason for Announcement:
Company Name:
Legacy Pharmaceutical Packaging
Brand Name:
Legacy
Product Description:
Losartan Potassium USP

Company Announcement

Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall. (more…)