InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter
InvaGen Pharmaceuticals is recalling Testosterone Cypionate Injection vials due to the presence of particulate matter. The affected lots were distributed nationwide in the U.S.A.
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 poses a risk of harm even without reported injuries.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Vial, Multiple-Dose. The recall is due to the presence of particulate matter in the product. The affected product is manufactured by Cipla Ltd. in India for Cipla USA, Inc.
The recall involves 75,968 vials distributed nationwide in the U.S.A. The specific lots affected are GH80216 (Exp 1/2020), GH80322 and GH80323 (Exp 2/2020), and GH90072 (Exp 12/2020). The product is a prescription-only medication intended for intramuscular use.
Consumers and healthcare providers should check their inventory for the listed lot numbers and expiration dates. If the product is found, it should be returned to the distributor or pharmacy. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Injectable Steroid
- Affected units
- 75,968
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 (4)
- Lots #: GH80216 Exp 1/2020
- GH80322
- GH80323 Exp 2/2020
- GH90072 Exp 12/2020.
UPCs (3)
- 0369097536374
- 0369097537371
- 0369097537319
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by InvaGen Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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