Recalls / Class III
Class IIID-0653-2017
Product
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
- Brand name
- Fluocinolone Acetonide
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Topical
- NDC
- 43386-069
- FDA application
- ANDA206422
- Affected lot / code info
- Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
Why it was recalled
Chemical Contamination
Recalling firm
- Firm
- Novel Laboratories, Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 390 & 400 Campus Drive, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 7,656 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-22
- FDA classified
- 2017-04-11
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0653-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.