Recalls / Class II
Class IID-0234-2022
Product
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
- Affected lot / code info
- Lot #: 07030002A, exp. date 02/2022
Why it was recalled
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 15,88 bottles
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2021-11-04
- FDA classified
- 2021-11-16
- Posted by FDA
- 2021-11-24
- Terminated
- 2022-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0234-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.