Drug recall D-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.
Reason for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Lots and codes
Lot #23804.034A, 23803.061A, Exp 9/2024
Recall details
- Recalling firm
- Azurity Pharmaceuticals, Inc., Wilmington, MA
- Quantity
- a) 16,471 vials; b) 43,096 vials
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 15, 2023
- Terminated
- December 4, 2023
Related products
- Testosterone Cypionate – drug information
- NDC 52536-625 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Wilshire Pharmaceuticals