Testosterone Cypionate Injectable Recalled Due to Manufacturing Sterility Deviation
Sun Pharmaceutical is recalling approximately 47,500 vials of Testosterone Cypionate Injection due to a manufacturing deviation that may have affected product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a manufacturing deviation affecting sterility of an injectable drug. No illnesses, injuries, or deaths have been reported in the source. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
Testosterone Cypionate Injection, USP, 200 mg/mL is being recalled. The product is manufactured by Sun Pharmaceutical Industries Ltd. in Gujarat, India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey. The recall involves approximately 47,500 single-dose vials from lot HAC3427A with an expiration date of August 2023.
The recall was initiated due to a manufacturing process deviation. A microbial excursion was detected during manufacturing that compromised the assurance of sterility for the affected vials. Sterility is a critical quality attribute for injectable medications.
The affected product was distributed nationwide within the United States. Healthcare providers, pharmacies, and patients with vials from the affected lot should identify and segregate this medication.
Individuals and healthcare providers in possession of vials from lot HAC3427A should not use the product and should contact Sun Pharmaceutical Industries or their healthcare provider for further guidance.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable / Hormone
- Hazard
- microbial-contamination
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: HAC3427A
- EXP Date: 08/2023
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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