Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
D-0567-2023May 17, 2023Piscataway, NJ
Preferred Pharmaceuticals, Inc.
Class IITerminated
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmac...
Reason: CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
D-0506-2023April 12, 2023Anaheim, CA
Direct Rx
Class IIOngoing
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
D-0507-2023April 12, 2023Dawsonville, GA
Direct Rx
Class IIOngoing
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
D-0508-2023April 12, 2023Dawsonville, GA
Direct Rx
Class IIOngoing
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
D-0509-2023April 12, 2023Dawsonville, GA
Preferred Pharmaceuticals, Inc.
Class IITerminated
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, ...
Reason: CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Reason: CGMP Deviations: Potential risk of Cross Contamination
D-0463-2023March 22, 2023Berlin, CT
Nanomaterials Discovery Corporation
Class IOngoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
D-0455-2023March 15, 2023Seattle, WA
GFA Production Xiamen Co. Ltd.
Class ITerminated
Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0247-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0251-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0250-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0246-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0245-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0248-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.