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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 481–500 of 1,000 recalls

Class IITerminated

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class II
Terminated

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

May 30, 2023 · DrugView details →
Class IITerminated

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent drug

May 30, 2023 · DrugView details →
Class IITerminated

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

Viatris Inc

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 25, 2023 · DrugView details →
Class IITerminated

Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).

Golden State Medical Supply Inc.

Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

May 25, 2023 · DrugView details →
Class IITerminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Fresenius Medical Care Holdings, Inc.

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

May 23, 2023 · DrugView details →
Class IITerminated

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Alpha Aromatics

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

May 16, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
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