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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 11321–11340 of 17,816 recalls

Class IIITerminated

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61

Actavis Inc

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

August 2, 2016 · DrugView details →

Class IITerminated

Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109

Isomeric Pharmacy Solution, LLC

Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.

August 1, 2016 · Drug

View details →

Class IITerminated

Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

Spectrum Laboratory Products, Inc.

Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.

August 1, 2016 · DrugView details →

Class ITerminated

Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502

Town and Country Compounding and Consultation Services

Non-Sterility; microbial contamination identified as Bacillus circulans

August 1, 2016 · DrugView details →

Class IITerminated

2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.

Sage Products LLC

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

July 29, 2016 · DrugView details →

Class IITerminated

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

Teva Pharmaceuticals USA

CGMP Deviations

July 29, 2016 · DrugView details →

Class ITerminated

COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.

Sage Products LLC

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

July 29, 2016 · DrugView details →

Class IITerminated

COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.

Sage Products LLC

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

July 29, 2016 · DrugView details →

Class IITerminated

Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).

Teva Pharmaceuticals USA

CGMP Deviations

July 29, 2016 · DrugView details →

Class IITerminated

C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067

Colonia Care Pharmacy

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

July 28, 2016 · DrugView details →

Class IITerminated

C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067

Colonia Care Pharmacy

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

July 28, 2016 · DrugView details →

Class IIITerminated

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Akorn, Inc.

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

July 27, 2016 · DrugView details →

Class IITerminated

Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

Class IITerminated

Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility

July 26, 2016 · DrugView details →

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