Recalls / Class III
Class IIID-0241-2017
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
- Affected lot / code info
- 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
Why it was recalled
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Recalling firm
- Firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1321 Murfreesboro Pike #, N/A, Nashville, Tennessee 37217-2726
Distribution
- Quantity
- 124,250 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-12-12
- FDA classified
- 2016-12-28
- Posted by FDA
- 2017-01-04
- Terminated
- 2018-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0241-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.