Drug product
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
D-0637-2021
Product summary
- Event
- Event 87990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,561 bottles for sale; 773 bottles for samples
- Official record key
drug-enforcement:D-0637-2021
Official wording
Reason: Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Code information: Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance