FDA Recall D-0212-2017

VIRTUS PHARMACEUTICALS OPCO II L · Nashville, TN

Class I — life-threatening Terminated 1116 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

Lot / code: Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.

Quantity: 94,643 bottles

Reason for recall

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

Recall record

Recall number: D-0212-2017
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide and Puerto Rico
Recall initiated: 2016-09-02
Classified by FDA Center: 2016-12-22
FDA published: 2016-12-28
Terminated: 2019-09-23
Recalling firm: VIRTUS PHARMACEUTICALS OPCO II L
Firm location: Nashville, TN

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