Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highw

FDA recall notice · announced July 20, 2022 · Sun Pharmaceutical Industries

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.

Reason for recall

cGMP - Water leakage

Notes

Distribution: USA Nationwide
Lot/code information: HAC4337A
Quantity: 50860 vials
Status: Terminated
Products in this recall event:
- Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Indu (D-1190-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.