Home / Recalls / VIRTUS PHARMACEUTICALS OPCO II L / D-0213-2017

D-0213-2017 Class I Terminated

Recalled by VIRTUS PHARMACEUTICALS OPCO II L — Nashville, TN

Recall Details

Product Type
Drugs
Report Date
December 28, 2016
Initiation Date
September 2, 2016
Termination Date
September 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,572 bottles

Product Description

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

Reason for Recall

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 30011601, Exp 01/18

Other recalls by VIRTUS PHARMACEUTICALS OPCO II L

  • D-0240-2017 Class III — Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dieta (December 12, 2016)
  • D-0238-2017 Class III — Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Die (December 12, 2016)
  • D-0241-2017 Class III — VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Ac (December 12, 2016)
  • D-0239-2017 Class III — Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Minera (December 12, 2016)
  • D-0212-2017 Class I — Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Ma (September 2, 2016)
  • D-0214-2017 Class I — Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx onl (September 2, 2016)