Why it was recalled
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0241-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 12, 2016
- FDA report date
- Jan 4, 2017
- Quantity
- 124,250 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIRTUS PHARMACEUTICALS OPCO II L
Original FDA data
Every field from FDA enforcement report D-0241-2017, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 76103
- Address
- 1321 Murfreesboro Pike #
- 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
- Postal code
- 37217-2726
- Report date
- Jan 4, 2017
- Product type
- Drugs
- Recall number
- D-0241-2017
- Classification
- Class III
- Recalling firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Product quantity
- 124,250 bottles
- Termination date
- Aug 21, 2018
- Reason for recall
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 12, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2016