Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lyne Laboratories, Inc., originally initiated on 04-13-2018 for the product Fluocinolone Acetonide Topical Oil, 0.01% (Body 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 64980-331-04, UPC 364980331043 The product was recalled due to subpotent drug. The product was distributed in To Be Entered and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0711-2018 | 04-13-2018 | 05-02-2018 | Class II | 12572 units | Fluocinolone Acetonide Topical Oil, 0.01% (Body 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 64980-331-04, UPC 364980331043 | Subpotent Drug | Terminated |
| D-0712-2018 | 04-13-2018 | 05-02-2018 | Class II | 17939 units | 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 | Subpotent Drug | Terminated |
| D-0713-2018 | 04-13-2018 | 05-02-2018 | Class II | 23453 units | 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 | Subpotent Drug | Terminated |
Recalled Products
