D-0489-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- February 15, 2023
- Termination Date
- December 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 16,471 vials; b) 43,096 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.
Reason for Recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Distribution Pattern
US Nationwide
Code Information
Lot #23804.034A, 23803.061A, Exp 9/2024