Prescription testosterone gel recalled due to out-of-specification potency
Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.
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: FDA Class II recall for superpotent testosterone gel. Although no illnesses or injuries have been reported, the excessive potency of a prescription hormone medication poses a potential risk of serious adverse health effects to patients. This meets the High severity criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Testosterone Gel 1% (25 mg per 2.5 g dose), supplied in 30-unit-dose packets per box. The affected lot is 1403180 with an expiration date of 10/2022.
The recall was initiated following out-of-specification assay results obtained during stability testing. These results indicate that the product is superpotent, meaning it contains a higher potency than the label specifies. The FDA has classified this as a Class II recall.
Approximately 12,354 cartons of the affected lot were distributed nationwide in the United States.
Persons who have this product should consult their healthcare provider or pharmacist regarding this recall.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 12,354
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: 1403180
- EXP. 10/2022
Distribution
Distributed nationwide across the United States.
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Similar recalls
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