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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug

VIRTUS PHARMACEUTICALS OPCO II L: Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Agency Publication Date: December 22, 2016
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Affected Products

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

Lot Numbers:
30051601
Product: 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.

Lot #: 30011601, Exp 01/18

Lot Numbers:
30011601
Product: Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

Lot #: 30031601, 30031602, Exp 01/18

Lot Numbers:
30031601

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75146
Status: Resolved
Manufacturer: VIRTUS PHARMACEUTICALS OPCO II L
Manufactured In: United States
Units Affected: 3 products (94,643 bottles; 10,572 bottles; 24,444 bottles)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.