D-0775-2016 Class III Terminated
FDA drug recall D-0775-2016 was initiated by Virtus Pharmaceuticals, Llc on January 15, 2016 and is designated Class III. Reason for recall: Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossin… The recall status is terminated (terminated August 21, 2018). Affected quantity: 1,139 bottles total.
Recall Details
- Product Type
- Drugs
- Report Date
- March 23, 2016
- Initiation Date
- January 15, 2016
- Termination Date
- August 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,139 bottles total
Product Description
Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
Reason for Recall
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Distribution Pattern
MI
Code Information
Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017, NDC 76439-264-10, UPC 376439264109