FDAClass IIApril 6, 2022

(ca) Gonadorelin recall: Sterility Concern

(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy

Why was (ca) Gonadorelin recalled?

Lack of sterility assurance.

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?

Lots: 749842 BUD: 7/13/2022; 749568 BUD: 7/12/2022; 752053 BUD: 7/23/2022; 752817 BUD: 7/25/2022; 757404 BUD: 8/21/2022; 757915 BUD: 8/23/2022; 757321 BUD: 8/20/2022; 753718 BUD: 7/30/2022

Product
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Recalling firm
Drug Depot, Inc., dba APS Pharmacy
Quantity
1843 vials
Distribution
Nationwide in the USA including Puerto Rico.
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls