Class II
Terminated
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
- Recall Initiated
- June 10, 2022
- Posted
- June 29, 2022
- Recall Number
- D-1154-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 47,500 vials
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Distribution
Nationwide within the United States
Lot / Code Info
Lot: HAC3427A, EXP Date: 08/2023
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