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.
Reported: June 29, 2022 Initiated: June 10, 2022 #D-1154-2022
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 47,500 vials
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 47,500 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 29, 2022. Severity: Moderate. Recall number: D-1154-2022.
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