Testosterone Cypionate Injectable Recalled for Manufacturing Quality Issues
Sun Pharmaceutical recalls 97,450 vials of Testosterone Cypionate Injection nationwide due to manufacturing deviations that could cause out-of-specification impurities.
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 classification for a prescription medication with confirmed manufacturing deviations that could affect product specification and purity. No illnesses or injuries have been reported, limiting the maximum score to 3 per the rubric.
Plain-English summary
Testosterone Cypionate Injection, USP 200 mg/mL, manufactured by Sun Pharmaceutical Industries Inc and distributed nationwide in the USA and Puerto Rico, is being recalled. The product is sold under NDC 62756-015-40, 62756-017-40, and 62756-016-40, with lot codes HAC1974A and HAC1978A and expiration date 06/2023.
The recall was initiated due to manufacturing deviations. Some lots of Testosterone Cypionate were previously rejected due to manufacturing issues that could cause the product to be out of specification for impurities. Lots made with the same active pharmaceutical ingredient are being recalled as a precaution, as they could potentially be affected by similar manufacturing deviations.
Approximately 97,450 vials are affected by this recall. The product is a prescription injectable used for testosterone replacement therapy.
Patients currently using this medication should consult their healthcare provider or pharmacist to determine if they have affected product. Healthcare providers and patients should not discontinue testosterone replacement therapy without medical guidance.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Affected units
- 97,450
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 (3)
- HAC1974A
- HAC1978A
- Exp 06/2023
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
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