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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

APS Pharmacy Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: March 29, 2022
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Summary

Drug Depot, Inc., doing business as APS Pharmacy, is recalling approximately 9,440 vials of various injectable medications due to a lack of sterility assurance. The recall includes products such as Gonadorelin and several formulations of Testosterone (Testosterone Cypionate combined with Anastrozole, DHEA, or Propionate) packaged in multi-dose 10ml vials. Using non-sterile injectable products can lead to serious health complications, though no injuries or incidents have been reported to date. These medications were sold nationwide and in Puerto Rico.

Risk

Medications that are intended to be sterile but lack sterility assurance pose a significant risk of causing serious infections when injected. These infections can be life-threatening or result in permanent medical issues.

What You Should Do

  1. This recall affects APS Pharmacy injectable medications including Gonadorelin and various Testosterone combinations (Testosterone Cypionate combined with Anastrozole, DHEA, or Propionate) sold in 10ml multi-dose vials.
  2. Check your medication packaging for lot numbers and 'Best Used By' (BUD) dates. Because this recall affects dozens of different batch codes, see the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact APS Pharmacy at 1-888-723-3332 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: GONADORELIN (5ML) 0.2 MG/ML INJECTABLE
Variants: 5ML fill, 10ML multi-dose vial, 0.2 MG/ML
Model:
Formula ID132227
Lot Numbers:
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)

Recall #: D-0728-2022

Product: (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE
Variants: 4ML fill, 10ML multi-dose vial, 0.2 MG/ML
Model:
Formula ID136345
Lot Numbers:
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)

Recall #: D-0729-2022

Product: TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML
Variants: 4ML, 10ML, 10ML multi-dose vial, 200MG/1MG/ML
Model:
Formula ID 115387
Formula ID 115125
Lot Numbers:
745383 (BUD 6/20/2022)
759295 (BUD 8/30/2022)
745749 (BUD 6/21/2022)
746272 (BUD 6/27/2022)

Recall #: D-0730-2022

Product: TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL 200MG/0.5MG/ML
Variants: 4ML, 10ML, 10ML multi-dose vial, 200MG/0.5MG/ML
Model:
Formula ID 136164
Formula ID 115962
Lot Numbers:
750851 (BUD 7/18/2022)
754549 (BUD 8/2/2022)

Recall #: D-0731-2022

Product: TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML
Variants: 5ML, 10ML, 10ML multi-dose vial, 200/10MG/ML
Model:
Formula ID 115678
Formula ID 115498
Lot Numbers:
746000 (BUD 6/26/2022)
751472 (BUD 7/20/2022)

Recall #: D-0732-2022

Product: TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil 160MG/20MG/ML
Variants: 10ML fill, 10ML multi-dose vial, 160MG/20MG/ML
Model:
Formula ID 115498
Lot Numbers:
759312 (BUD 8/30/2022)

Recall #: D-0733-2022

Product: TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML
Variants: 10ML multi-dose vial, 200 MG/ML
Model:
Formula ID 76681
Lot Numbers:
754381 (BUD 8/1/2022)

Recall #: D-0734-2022

Product: TESTOSTERONE CYPIONATE *GS* 80 MG/ML
Variants: 2ML fill, 10ML multi-dose vial, 80 MG/ML
Model:
Formula ID 127492
Lot Numbers:
746269 (BUD 6/27/2022)

Recall #: D-0735-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89808
Status: Resolved
Manufacturer: Drug Depot, Inc., dba APS Pharmacy
Sold By: APS Pharmacy
Manufactured In: United States
Units Affected: 8 products (6017 vials; 1843 vials; 846 vials; 73 vials; 620 vials; 0; 24 vials; 17 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.