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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 6441–6460 of 17,773 recalls

Class IITerminated

25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or expiration date.

November 27, 2019 · DrugView details →

Class IITerminated

Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09

SCA Pharmaceuticals, LLC

Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).

November 26, 2019 · DrugView details →

Class IITerminated

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

AuroMedics Pharma LLC

Discoloration: Product complaints of discoloration after reconstitution of vials.

November 25, 2019 · DrugView details →

Class IIITerminated

VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.

Apothecus Pharmaceutical Corp.

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

November 25, 2019 · DrugView details →

Class IITerminated

Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011

OraLabs, Incorporated

Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.

November 25, 2019 · DrugView details →

Class IITerminated

Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA

Medisca, Inc.

Failed Impurities/Degradation Specifications

November 25, 2019 · DrugView details →

Class IIOngoing

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Amneal Pharmaceuticals, Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

November 22, 2019 · DrugView details →

Class IIOngoing

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Amneal Pharmaceuticals, Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

November 22, 2019 · DrugView details →

Class IIOngoing

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

Amneal Pharmaceuticals, Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

November 22, 2019 · DrugView details →

Class IIOngoing

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Amneal Pharmaceuticals, Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

November 22, 2019 · DrugView details →

Class IIOngoing

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

Amneal Pharmaceuticals, Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

November 22, 2019 · DrugView details →

Class IITerminated

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

Pacira Pharmaceuticals, Inc.

Sub Potent Drug: Out of Specification (OOS)

November 21, 2019 · DrugView details →

Class IITerminated

Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01

Preferred Pharmaceuticals, Inc

Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

November 21, 2019 · DrugView details →

Class IIITerminated

SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Idelle Labs

Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.

November 20, 2019 · DrugView details →

Class IITerminated

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

American Health Packaging

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

November 20, 2019 · DrugView details →

Class ITerminated

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

AuroMedics Pharma LLC

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

November 20, 2019 · DrugView details →

Class IIITerminated

SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Idelle Labs

Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.

November 20, 2019 · DrugView details →

Class ITerminated

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05

AuroMedics Pharma LLC

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

November 20, 2019 · DrugView details →

Class IIITerminated

SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Idelle Labs

Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.

November 20, 2019 · DrugView details →

Class IIITerminated

SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Idelle Labs

Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.

November 20, 2019 · DrugView details →

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