Recalls / Class II
Class IID-0489-2023
Product
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.
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDC
- 52536-625
- FDA application
- ANDA206368
- Affected lot / code info
- Lot #23804.034A, 23803.061A, Exp 9/2024
Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recalling firm
- Firm
- Azurity Pharmaceuticals, Inc.
- Manufacturer
- Wilshire Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 841 Woburn St, Wilmington, Massachusetts 01887-3414
Distribution
- Quantity
- a) 16,471 vials; b) 43,096 vials
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2023-02-15
- FDA classified
- 2023-03-31
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0489-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.