FDAClass IIFebruary 23, 2022

Alprazolam Tablets recall: CGMP Deviations

Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

Why was Alprazolam Tablets recalled?

cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.

Product
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Recalling firm
ANI Pharmaceuticals, Inc.
Quantity
70,788 bottles
Distribution
Nationwide within the United States
Recall date
February 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls