Drug product
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200
D-0712-2018
Product summary
- Event
- Event 79860
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17939 units
- Official record key
drug-enforcement:D-0712-2018
Official wording
Reason: Subpotent Drug
Code information: Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018
Distribution pattern: to be entered
Derived failure modes
-
Potency or specification failure
Subpotent