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.
Reported: April 12, 2023 Initiated: February 15, 2023 #D-0489-2023
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.
Details
- Recalling Firm
- Azurity Pharmaceuticals, Inc.
- Units Affected
- a) 16,471 vials; b) 43,096 vials
- Distribution
- US Nationwide
- Location
- Wilmington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Azurity Pharmaceuticals, Inc.. Units affected: a) 16,471 vials; b) 43,096 vials.
Why was this product recalled? ▼
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0489-2023.
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