March 2022 FDA Recall Drug by Golden State Medical Supply Inc.
D-0654-2022 - CGMP Deviation

This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on March 2, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in Distributed to 1 wholesaler/distributor and the recall is currently terminated.

Recall Number: D-0654-2022

Reason for Recall
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Initiated
03-02-2022
Reported
03-23-2022
Quantity
401 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89712
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to 1 wholesaler/distributor
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2022
Product Description About Product Description
Full technical description of the product.
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.

Batch or Lot Expiration Information

Lot# : GS027852, Expiry: 06/2022.