PlainRecordsFDA · Drug recall
Testosterone Cypionate Injection…
- Date
- July 13, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- Product
- Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
- Reason
- CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
- Distribution pattern
- nationwide.
- Quantity
- 27 vials
- Codes and lots
- Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
- Recall started
- June 3, 2022
- Recall number
- D-1176-2022
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1176-2022. The agency record governs; check it and the company before acting.