Drug product
Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
D-0238-2017
Product summary
- Event
- Event 76103
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,537 bottles
- Official record key
drug-enforcement:D-0238-2017
Official wording
Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Code information: Lots #: 41505136 Exp. Date 5/30/2017 and 41605134 Exp. date 4/30/2018
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations