Why it was recalled
Lack of Assurance of Sterility
Product description
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
Lot numbers, UPCs & expiration codes
Batch#: a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.
Where it was sold
Nationwide USA and 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-1231-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2022
- FDA report date
- Jul 20, 2022
- Quantity
- 4,219 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
Original FDA data
Every field from FDA enforcement report D-1231-2022, exactly as published.
Show all FDA fields
- City
- Nicholasville
- State
- KY
- Status
- Ongoing
- Country
- United States
- Event ID
- 89909
- Address
- 200 Moore Dr
- Code information
- Batch#: a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.
- Postal code
- 40356-8512
- Report date
- Jul 20, 2022
- Product type
- Drugs
- Recall number
- D-1231-2022
- Classification
- Class II
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Product quantity
- 4,219 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Mar 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2022