Recalls / Class III
Class IIID-0100-2021
Product
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Topical
- NDCs
- 0591-2921, 0591-3216, 0591-3217
- FDA application
- ANDA076737
- Affected lot / code info
- Lot Number: 1351104, Exp 08/2021
Why it was recalled
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 12,088 cartons
- Distribution pattern
- Product was distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2020-11-11
- FDA classified
- 2020-11-20
- Posted by FDA
- 2020-11-25
- Terminated
- 2021-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0100-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.