Testosterone Cypionate Injection recall: Sterility Concern
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.
Why was Testosterone Cypionate Injection recalled?
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: HAC3427A, EXP Date: 08/2023
- Product
- 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.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 47,500 vials
- Distribution
- Nationwide within the United States
- Recall date
- June 29, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)