The Recall Desk
HighFDA (Drugs)·D-0729-2022·Announced 2022-04-06

Gonadorelin injectable recalled for lack of sterility assurance

Drug Depot recalls 1,843 vials of Gonadorelin injectable nationwide due to lack of sterility assurance. Patients should consult their healthcare provider regarding previously dispensed doses.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. The lack of sterility assurance in an injectable poses a potential microbial contamination risk, warranting a High severity classification.

Plain-English summary

Drug Depot, Inc., operating as APS Pharmacy, is recalling 1,843 vials of Gonadorelin (4mL) 0.2 mg/mL injectable due to lack of sterility assurance. The affected product was packaged in multi-dose 10mL vials and distributed nationwide in the United States, including Puerto Rico.

Eight specific lots are involved in this recall: Lot 749842 (BUD 7/13/2022), Lot 749568 (BUD 7/12/2022), Lot 752053 (BUD 7/23/2022), Lot 752817 (BUD 7/25/2022), Lot 757404 (BUD 8/21/2022), Lot 757915 (BUD 8/23/2022), Lot 757321 (BUD 8/20/2022), and Lot 753718 (BUD 7/30/2022).

Patients who received this medication should contact their healthcare provider or pharmacist to discuss their treatment options. No illnesses or injuries have been reported at this time. The FDA classifies this as a Class II recall.

The recalled product

Product
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Category
Drug — Injectable Medication
Hazard
Affected units
1,843

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Drug Depot, Inc., dba APS Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Drug Depot, Inc., dba APS Pharmacy

See all →

Same hazard · lack of sterility

See all →