PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

Reported: February 23, 2022 Initiated: February 15, 2022 #D-0564-2022

Product Description

Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

Reason for Recall

cGMP Deviations

Details

Recalling Firm
ANI Pharmaceuticals, Inc.
Units Affected
73,920 bottles
Distribution
Nationwide within the United States
Location
Baudette, MN

Frequently Asked Questions

What product was recalled?
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977. Recalled by ANI Pharmaceuticals, Inc.. Units affected: 73,920 bottles.
Why was this product recalled?
cGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 23, 2022. Severity: Moderate. Recall number: D-0564-2022.