Sun Pharmaceutical Recalls Testosterone Cypionate Injection Due to Labeling Error
Sun Pharmaceutical Industries Inc. is recalling Testosterone Cypionate Injection due to an incorrect lot number on secondary packaging.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is limited to a packaging labeling error.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 36,275 cartons of Testosterone Cypionate Injection, USP CIII 200mg/ml for intramuscular use. The product is distributed nationwide and is identified by Lot JKX2553A.
The recall was initiated because of an incorrect lot number on the secondary packaging. This is a documentation and labeling issue rather than a defect in the drug product itself.
Consumers and healthcare providers should check their inventory for this specific lot number and packaging. If found, the product should be returned to the distributor or the recalling firm for credit.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 36,275
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)
- Lot JKX2553A
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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