Recalls / Class II
Class IID-0686-2022
Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
- Affected lot / code info
- Batch: a) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 355,672 tubes
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-15
- FDA classified
- 2022-03-21
- Posted by FDA
- 2022-03-30
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0686-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.