FDA recall D-1044-2016

Product

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

Reason for recall

Chemical Contamination: Bottles may contain broken dessicants

Distribution

Nationwide & Puerto Rico.

Key facts

Status

Terminated

Initiation date

2016-05-13

Report date

2016-06-29

Termination date

2018-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2016