Testosterone Cypionate Injection recalled over manufacturing violations
- Recall date
- February 15, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Azurity Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) an…
- Recall number
- D-0489-2023
- FDA classification
- Class II
- Brand / firm
- Azurity Pharmaceuticals, Inc.
- Sold / distributed
- US Nationwide
Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
Get recall alerts
Free email alert whenever Azurity Pharmaceuticals, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Azurity Pharmaceuticals, Inc.