Hyoscyamine Sulfate recall: Subpotent
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN…
Why was Hyoscyamine Sulfate recalled?
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
- Product
- Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN…
- Recalling firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Quantity
- 94,643 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- December 28, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)