Drug 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.
D-0489-2023
Product summary
- Event
- Event 91710
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 16,471 vials; b) 43,096 vials
- Official record key
drug-enforcement:D-0489-2023
Official wording
Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Code information: Lot #23804.034A, 23803.061A, Exp 9/2024
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.