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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30

Olympia Compounding Pharmacy

Class I - Dangerous

Sub Potent

Mar 8, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Defective container

Mar 14, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Defective container

Mar 14, 2022 Prescription Drugs Nationwide View Details →

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Defective container

Mar 14, 2022 Prescription Drugs Nationwide View Details →

ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202

Rock Town Distillery

Class I - Dangerous

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

Mar 10, 2022 Other Drugs View Details →

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

Fresenius Kabi USA

Class I - Dangerous

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Mar 4, 2022 Prescription Drugs Nationwide View Details →

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Other Drugs Nationwide View Details →

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

Blaine Labs

Class I - Dangerous

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

Jan 25, 2022 Other Drugs Nationwide View Details →

Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →

Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00

Olympia Compounding Pharmacy

Class I - Dangerous

Super Potent and Failed Reconstitution Time

Mar 8, 2022 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.

Teligent Pharma

Class I - Dangerous

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

Mar 15, 2022 Prescription Drugs Nationwide View Details →