Testosterone Cypionate Injection Recalled for Water Leakage in Manufacturing
Sun Pharmaceutical recalls 50,860 vials of Testosterone Cypionate Injection due to water leakage during manufacturing that could affect product sterility. The firm-initiated recall was reported in July 2022 and affects nationwide distribution.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of an injectable medication due to cGMP water leakage that could compromise product sterility. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High rating.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 50,860 vials of Testosterone Cypionate Injection, USP, 200 mg/mL due to a cGMP manufacturing defect. Water leakage was detected at the manufacturing facility that could potentially compromise the sterility of this injectable medication. The firm initiated the recall on June 21, 2022, and it was reported to the FDA on July 20, 2022. The recall affects nationwide distribution in the USA.
The affected product is Testosterone Cypionate Injection, an intramuscular injectable medication with lot code HAC4337A and NDC 62756-015-40. The product was manufactured by Sun Pharmaceuticals Industries Ltd. in Halol-Baroda, Gujarat, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey. This is a prescription-only, controlled substance (Schedule III).
Patients currently taking this medication should not stop their treatment without consulting their healthcare provider. Those who have vials with lot code HAC4337A should contact their pharmacy or healthcare provider to determine if their medication is affected and obtain guidance on replacement therapy if needed.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable / Hormone
- Affected units
- 50,860
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 (1)
- HAC4337A
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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