FDAFDA · Food and drugs·Recall number D-1153-2022
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.
Published June 29, 2022 · Recall initiated: June 3, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0362756017405
- Lot
- HAC1974A, HAC1978A, Exp 06/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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