FDA recall D-0213-2017

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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-09-02

Report date

2016-12-28

Termination date

2019-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2017