FDAClass IIIJune 29, 2016

Hyoscyamine Sulfate Sublingual Tablets recall: Contamination

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

Why was Hyoscyamine Sulfate Sublingual Tablets recalled?

Chemical Contamination: Bottles may contain broken dessicants

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 #: 638J011A

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
Recalling firm
Virtus Pharmaceuticals, Llc
Quantity
24,614 bottles
Distribution
Nationwide & Puerto Rico.
Recall date
June 29, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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