Drug 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.
D-0212-2017
Product summary
- Event
- Event 75146
- Status
- Terminated
- Classification
- Class I
- Quantity
- 94,643 bottles
- Official record key
drug-enforcement:D-0212-2017
Official wording
Reason: Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Code information: Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
superpotent