Teva Recalls Testosterone Gel Due to High Out-of-Specification Assay Results
Teva Pharmaceuticals USA is recalling Testosterone Gel 1% due to high out-of-specification assay results found during stability testing.
What this means for you
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 III, which by definition is unlikely to cause adverse health consequences, fitting the criteria for a moderate severity score involving minor labeling or specification errors.
Plain-English summary
Teva Pharmaceuticals USA is recalling 12,088 cartons of Testosterone Gel 1%, 2.5 grams per unit dose. The product is packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17) with 30 packets per carton (NDC 0591-3216-30). The specific lot number is 1351104, with an expiration date of 08/2021.
The recall was initiated because high out-of-specification assay results were obtained during stability testing. This indicates the product may contain more of the active ingredient than intended.
The product was distributed nationwide in the USA. It was manufactured by Actavis Laboratories UT, Inc., in Salt Lake City, UT, and distributed by Actavis Pharma, Inc., in Parsippany, NJ. Consumers should check their medication for the specific lot number and expiration date listed above and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Affected units
- 12,088
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 Number: 1351104
- Exp 08/2021
Distribution
Distributed nationwide across the United States.
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