Sun Pharmaceutical Recalls Testosterone Cypionate Injection Due to Particulate Matter
Sun Pharmaceutical Industries is recalling Testosterone Cypionate Injection vials because organic and inorganic particulate matter was detected in the product.
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: The recall is classified as FDA Class II, and the hazard involves particulate matter in an injectable drug, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Testosterone Cypionate Injection, USP, 200 mg/mL, 10 mL vials. The recall affects 5,215 units of the product, which is distributed nationwide within the United States. The specific lot number is JKS0280A, with an expiration date of 06/2019. The product is a prescription-only medication intended for intramuscular use.
The recall was initiated due to the presence of particulate matter, specifically organic and inorganic compounds, detected in the vials of the product. This contamination poses a potential risk to patients who administer the injection.
Consumers and healthcare providers should stop using the affected product immediately. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions. The recalling firm is Sun Pharmaceutical Industries, Inc., located in Cranbury, NJ.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 5,215
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 #: JKS0280A
- Exp. 06/2019
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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