The Recall Desk
HighFDA (Drugs)·D-0728-2022·Announced 2022-04-06

FDA Recalls Gonadorelin Injectable Vials for Lack of Sterility Assurance

Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.

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 recall without reported illnesses, injuries, or infections. The hazard—lack of sterility assurance on injectable products—represents a significant potential risk, fitting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Drug Depot, Inc., operating as APS Pharmacy, is recalling Gonadorelin 0.2 mg/mL injectable solution packaged in multi-dose 10 mL vials (Formula ID132227). The product is distributed nationwide, including Puerto Rico.

The recall is being issued due to lack of sterility assurance. Injectable products must maintain strict sterile conditions to prevent potential infections in patients.

Approximately 6,017 vials are affected across 17 lot numbers with expiration dates ranging from June through August 2022. The lot numbers and their specific expiration dates are identified by the FDA. Patients who may have received this product should contact their healthcare provider.

The recalled product

Product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Category
Drug — Injectable
Hazard
  • lack-of-sterility
  • infection-risk

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 (17)

  • Lots: 745708 BUD: 6/21/2022
  • 753364 BUD: 7/27/2022
  • 752508 BUD: 7/24/2022
  • 750313 BUD: 7/16/2022
  • 753020 BUD: 7/26/2022
  • 747712 BUD: 7/4/2022
  • 747974 BUD: 7/5/2022
  • 754802 BUD: 8/3/2022
  • 751158 BUD: 7/19/2022
  • 756837 BUD: 8/16/2022
  • 748939 BUD: 7/10/2022
  • 750842 BUD: 7/18/2022
  • 755742 BUD: 8/8/2022
  • 758691 BUD: 8/28/2022
  • 758432 BUD: 8/27/2022
  • 758975 BUD: 8/29/2022
  • 756643 BUD: 8/15/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category