Drug Recalls

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Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.

Multiple Drug Recalls - Mckesson Medical-Surgical Inc. Corporate Office

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).

Wed May 07 2025

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.

TIROFIBAN

Wed May 07 2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

NICARDIPINE HYDROCHLORIDE

Wed May 07 2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

WEGOVY (SEMAGLUTIDE)

Wed May 07 2025

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

Multiple Drug Recalls - Denver Solutions, LLC DBA Leiters Health

Wed Apr 30 2025

Lack of Assurance of Sterility: Leaking/damaged syringes.

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

Wed Apr 30 2025

CGMP Deviations

CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)

Wed Apr 30 2025

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Apr 30 2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Multiple Drug Recalls - Pharmadel, LLC

Wed Apr 30 2025

cGMP deviations

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

Wed Apr 30 2025

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

HALOPERIDOL DECANOATE

Wed Apr 30 2025

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

Wed Apr 30 2025

CGMP Deviations

Multiple Drug Recalls - Apipharma

Wed Apr 30 2025

CGMP Deviations

LEVETIRACETAM (LEVETIRACETAM INJECTION)

Wed Apr 23 2025

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Wed Apr 23 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

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 23 2025

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

Wed Apr 23 2025

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

TESTOSTERONE CYPIONATE

Wed Apr 23 2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

SODIUM CHLORIDE

Wed Apr 16 2025

Presence of Particulate Matter

SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR)

Wed Apr 16 2025

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Multiple Drug Recalls - Glenmark Pharmaceuticals Inc., USA

Wed Apr 16 2025

CGMP Deviations

VENLAFAXINE

Wed Apr 16 2025

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

GABAPENTIN

Wed Apr 16 2025

Cross Contamination

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 16 2025

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Multiple Drug Recalls - Somerset Therapeutics Private Limited

Wed Apr 16 2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Multiple Drug Recalls - Alchemee, LLC

Wed Apr 16 2025

Chemical contamination: Presence of benzene

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Apr 09 2025

CGMP Deviations: Due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

VORICONAZOLE

Wed Apr 09 2025

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

ATORVASTATIN CALCIUM

Wed Apr 09 2025

Failed dissolution specifications: lower than specifications

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 09 2025

CGMP deviations: Results of the finished product is above the Agency's current recommended limit of a nitrosamine, N-Nitroso-Desmethyl Chlorpromazine impurity.

TOLTERODINE TARTRATE (TOLTERODINE)

Wed Apr 09 2025

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Wed Apr 09 2025

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

Wed Apr 02 2025

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.