Sun Pharmaceutical Recalls Testosterone Cypionate Injection Due to Particulate Matter
Sun Pharmaceutical Industries, Inc. is recalling 83,188 vials of Testosterone Cypionate Injection due to the presence of particulate matter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is particulate matter without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 83,188 single-dose vials of Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL vial, for intramuscular use. The recall was initiated due to the presence of particulate matter in the product.
The affected product is distributed nationwide and is identified by lot codes JKR0744A, JKR0745A, JKR0750A, and JKR0795A, with an expiration date of 09/18. The product is manufactured by Sun Pharma Ind. Ltd. in India and distributed by Sun Pharma Ind. Inc. in New Jersey.
Consumers and healthcare providers should stop using the affected vials and contact Sun Pharmaceutical Industries, Inc. for further instructions or a refund.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 83,188
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 (5)
- JKR0744A
- JKR0745A
- JKR0750A
- JKR0795A
- Exp. 09/18
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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