Drug Recalls

TIMOLOL MALEATE

Wed Feb 12 2025

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

CARVEDILOL

Wed Feb 12 2025

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

GUAIFENESIN AND CODEINE PHOSPHATE

Wed Feb 12 2025

Superpotent; sodium benzoate preservative

GRANIX (TBO-FILGRASTIM)

Wed Feb 12 2025

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

HYDRALAZINE HYDROCHLORIDE

Wed Feb 12 2025

Failed Impurities/Degradation Specifications

Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

Wed Feb 12 2025

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

Wed Feb 12 2025

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

POTASSIUM CHLORIDE

Wed Feb 12 2025

Failed Dissolution Specifications.

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2

Wed Feb 05 2025

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Feb 05 2025

Failed Impurities/Degradation Specifications: Due to presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit of 5 ppm.

INFLECTRA (INFLIXIMAB-DYYB)

Wed Feb 05 2025

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Multiple Drug Recalls - Astellas Pharma US Inc.

Wed Feb 05 2025

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

Wed Jan 29 2025

CGMP Deviations; product intended for quarantine was inadvertently distributed

Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3

Wed Jan 29 2025

CGMP Deviations: lack of adequate release testing.

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

Wed Jan 29 2025

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

CARDURA (DOXAZOSIN MESYLATE)

Wed Jan 22 2025

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

CLOBAZAM

Wed Jan 22 2025

Presence of Foreign Tablets/Capsules

GLIPIZIDE

Wed Jan 22 2025

Failed Dissolution Specifications:

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Wed Jan 22 2025

Non-Sterility

Multiple Drug Recalls - Akron Pharma, Inc.

Wed Jan 22 2025

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

METHADONE HYDROCHLORIDE

Wed Jan 15 2025

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

METFORMIN ER 500 MG

Wed Jan 15 2025

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 15 2025

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

PROGESTERONE

Wed Jan 15 2025

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.

Wed Jan 15 2025

Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

COLCHICINE

Wed Jan 15 2025

Out of specification observed during the accelerated stability conditions for the 30 count bottles.

CIPROFLOXACIN

Wed Jan 15 2025

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

CLOBAZAM

Wed Jan 15 2025

Presence of Foreign Tablets/Capsules

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.

Wed Jan 15 2025

Failed Stability Specifications

CLONAZEPAM

Wed Jan 15 2025

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

MEDROXYPROGESTERONE ACETATE

Wed Jan 15 2025

CGMP Deviations

NITROFURANTOIN (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS)

Wed Jan 08 2025

Failed Dissolution Specifications

DAPSONE

Wed Jan 08 2025

Crystallization

LEVOTHYROXINE SODIUM

Wed Jan 08 2025

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Multiple Drug Recalls - Hikma Injectables USA Inc

Wed Jan 08 2025

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Multiple Drug Recalls - AvKARE

Wed Jan 08 2025

LABELING: LABEL MIX-UP

ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE)

Wed Jan 08 2025

Failed Impurities/Degradation Specifications

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

Wed Jan 08 2025

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Wed Jan 01 2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

TECHNETIUM TC 99M SESTAMIBI

Wed Jan 01 2025

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

CHLORPROMAZINE HYDROCHLORIDE

Wed Jan 01 2025

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

Wed Jan 01 2025

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.

NEBIVOLOL

Wed Dec 25 2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Multiple Drug Recalls - Regenerative Processing Plant, LLC

Wed Dec 25 2024

Lack of Sterility Assurance

OLANZAPINE

Wed Dec 25 2024

Failed Impurities/Degradation Specifications

Multiple Drug Recalls - Keystone Industries

Wed Dec 25 2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

DIHYDROERGOTAMINE MESYLATE

Wed Dec 25 2024

Discoloration