Why it was recalled
Lack of sterility assurance.
Product description
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
Lot numbers, UPCs & expiration codes
Lots: a)746000 BUD: 6/26/2022; b) 751472 BUD: 7/20/2022
Where it was sold
Nationwide in the USA including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0732-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 620 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Drug Depot, Inc., dba APS Pharmacy
Original FDA data
Every field from FDA enforcement report D-0732-2022, exactly as published.
Show all FDA fields
- City
- Palm Harbor
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89808
- Address
- 34911 Us Highway 19 N Ste 600
- Code information
- Lots: a)746000 BUD: 6/26/2022; b) 751472 BUD: 7/20/2022
- Postal code
- 34684-1921
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0732-2022
- Classification
- Class II
- Recalling firm
- Drug Depot, Inc., dba APS Pharmacy
- Product quantity
- 620 vials
- Termination date
- Oct 5, 2023
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
- Recall initiation date
- Mar 23, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2022