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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 3861–3880 of 17,755 recalls

Class IITerminated

Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →

Class IITerminated

TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.

Vitae Enim Vitae Scientific, Inc.

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

March 14, 2022 · DrugView details →

Class IITerminated

Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.

Vitae Enim Vitae Scientific, Inc.

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

March 14, 2022 · DrugView details →

Class IITerminated

PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.

Vitae Enim Vitae Scientific, Inc.

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

March 14, 2022 · DrugView details →

Class IITerminated

Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

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