FDA Drug Class I — Most Serious

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.

Hazard

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

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Products

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.
Brand
VIRTUS PHARMACEUTICALS OPCO II L
UPC
Lot #: 30011601, Exp 01/18

Units Affected

10,572 bottles

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