Drug product
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
D-0342-2019
Product summary
- Event
- Event 81775
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2055 tubes
- Official record key
drug-enforcement:D-0342-2019
Official wording
Reason: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Code information: Lot #: 129114 Exp. 06/2019; 131927,133239 Exp. 03/2020; 126292, Exp.01/2019.
Distribution pattern: United States, Maldives, Canada, United Arab Emirates, and New Zealand
Derived failure modes
-
Potency or specification failure
Subpotent