Drug product
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046
D-0713-2018
Product summary
- Event
- Event 79860
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23453 units
- Official record key
drug-enforcement:D-0713-2018
Official wording
Reason: Subpotent Drug
Code information: Lot #: FR1601, FR1602, Exp. 05/2018
Distribution pattern: to be entered
Derived failure modes
-
Potency or specification failure
Subpotent