FDA-Drug2016-12-28Class I
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.
VIRTUS PHARMACEUTICALS OPCO II L
Hazard
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Sold states
Nationwide and Puerto Rico
Affected count
10,572 bottles
Manufactured in
1321 Murfreesboro Pike #, N/A, Nashville, TN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2017Don't want to check this manually?
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