Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Product description
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.
Lot numbers, UPCs & expiration codes
Lot #23804.034A, 23803.061A, Exp 9/2024
Where it was sold
US Nationwide
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-0489-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- a) 16,471 vials; b) 43,096 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Azurity Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0489-2023, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 91710
- Address
- 841 Woburn St
- Code information
- Lot #23804.034A, 23803.061A, Exp 9/2024
- Postal code
- 01887-3414
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0489-2023
- Classification
- Class II
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Product quantity
- a) 16,471 vials; b) 43,096 vials
- Termination date
- Dec 4, 2023
- Reason for recall
- cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Feb 15, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 31, 2023