Drug Recalls

Sage Products Inc

Class II Terminated

Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral ...

Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

D-0375-2018 February 21, 2018 Cary, IL

DLC Laboratories, Inc

Class II Terminated

Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 9...

Reason: Microbial Contamination of Non-Sterile Products.

D-0241-2018 January 31, 2018 Paramount, CA

Unichem Pharmaceuticals Usa Inc

Class II Terminated

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Phar...

Reason: Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

D-0228-2018 January 24, 2018 Hasbrouck Heights, NJ

Pharmatech LLC

Class II Terminated

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC...

Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

D-0225-2018 January 24, 2018 Davie, FL

Pharmatech LLC

Class II Terminated

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- N...

Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

D-0227-2018 January 24, 2018 Davie, FL

Pharmatech LLC

Class II Terminated

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- N...

Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

D-0224-2018 January 24, 2018 Davie, FL

Pharmatech LLC

Class II Terminated

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- ...

Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

D-0226-2018 January 24, 2018 Davie, FL

Pfizer Manufacturing Deutschland GmbH

Class II Terminated

FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING

Reason: Microbial Contamination of Non-Sterile Products

D-0212-2018 January 17, 2018 Freiburg im Breisgau, N/A

Woodfield Pharmaceutical, LLC

Class II Terminated

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16

Reason: Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

D-0210-2018 January 17, 2018 Houston, TX

L. Perrigo Company

Class II Terminated

Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01

Reason: Microbial Contamination of Non-Sterile Products

D-0128-2018 December 27, 2017 Allegan, MI

Sun Pharmaceutical Industries, Inc.

Class II Terminated

Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratori...

Reason: Microbial Contamination of Non-Sterile Products

D-0109-2018 December 20, 2017 Cranbury, NJ

Taro Pharmaceuticals U.S.A., Inc.

Class III Terminated

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

Reason: Cross contamination with other products: traces of Dapsone were found in the finished product.

D-0146-2018 November 1, 2017 Hawthorne, NY

Inopak Ltd

Class II Terminated

Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood...

Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump

D-0002-2018 October 11, 2017 Ringwood, NJ

Inopak Ltd

Class II Terminated

Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ

Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

D-0004-2018 October 11, 2017 Ringwood, NJ

Inopak Ltd

Class II Terminated

Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456

Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

D-0003-2018 October 11, 2017 Ringwood, NJ

Centurion Labs, LLC

Class II Terminated

Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, ...

Reason: Microbial contamination of Non-sterile Products; potential B. cepacia contamination

D-1141-2017 September 20, 2017 Birmingham, AL

Centurion Labs, LLC

Class II Terminated

Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-0...

Reason: Microbial contamination of Non-sterile Products; potential B. cepacia contamination

D-1140-2017 September 20, 2017 Birmingham, AL

Mid Valley Pharmaceutical

Class II Terminated

Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvall...

Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

D-1135-2017 September 20, 2017 Raymondville, TX

Mid Valley Pharmaceutical

Class II Terminated

Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals...

Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

D-1136-2017 September 20, 2017 Raymondville, TX

The Harvard Drug Group

Class II Terminated

Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 0...