Drug 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
D-1044-2016
Product summary
- Event
- Event 74251
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24,614 bottles
- Official record key
drug-enforcement:D-1044-2016
Official wording
Reason: Chemical Contamination: Bottles may contain broken dessicants
Code information: Lot #: 638J011A
Distribution pattern: Nationwide & Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination