Drug product
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
D-0341-2019
Product summary
- Event
- Event 81775
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5363 tubes
- Official record key
drug-enforcement:D-0341-2019
Official wording
Reason: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Code information: Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020; 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020
Distribution pattern: United States, Maldives, Canada, United Arab Emirates, and New Zealand
Derived failure modes
-
Potency or specification failure
Subpotent