Drug product
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
D-0241-2017
Product summary
- Event
- Event 76103
- Status
- Terminated
- Classification
- Class III
- Quantity
- 124,250 bottles
- Official record key
drug-enforcement:D-0241-2017
Official wording
Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Code information: Lots #: 21506124 Exp. Date 5/30/2017, 21511151 Exp. date 10/30/2017, 21511151A Exp. Data 10/30/2017, 21512163 Exp. date 11/30/2017, 21512164 Exp. date 11/30/2017
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations