Recalls / Class III
Class IIID-1518-2019
Product
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
- Brand name
- Nystatin And Triamcinolone Acetonide
- Generic name
- Nystatin And Triamcinolone Acetonide
- Active ingredients
- Nystatin, Triamcinolone Acetonide
- Route
- Topical
- NDC
- 68180-545
- FDA application
- ANDA208205
- Affected lot / code info
- Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 33,939 tubes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-07-17
- FDA classified
- 2019-07-25
- Posted by FDA
- 2019-07-31
- Terminated
- 2020-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1518-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.