Drug product
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
D-0239-2017
Product summary
- Event
- Event 76103
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,406 bottles
- Official record key
drug-enforcement:D-0239-2017
Official wording
Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Code information: Lots #: 21511137 Exp. date 10/30/2017
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations