PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Reported: March 22, 2023 Initiated: March 2, 2023 #D-0460-2023

Product Description

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Reason for Recall

CGMP Deviations: Potential risk of Cross Contamination

Details

Units Affected
N/A
Distribution
USA nationwide.
Location
Berlin, CT

Frequently Asked Questions

What product was recalled?
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.. Recalled by Breckenridge Pharmaceutical, Inc. Units affected: N/A.
Why was this product recalled?
CGMP Deviations: Potential risk of Cross Contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on March 22, 2023. Severity: Moderate. Recall number: D-0460-2023.