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Class III: unlikely to cause harmTerminated

Virtus Pharmaceuticals Hyoscyamine Sulfate Sublingual Tablets Recall

Hyoscyamine Sulfate Sublingual Tablets, 0

Virtus Pharmaceuticals, Llc · Tampa, FL

Risk level
Class III
Reported by FDA
Jun 29, 2016
Recall ID
D-1044-2016
Check your lot numberHow we source this data

Summary

Virtus Pharmaceuticals recalled Hyoscyamine Sulfate Sublingual Tablets starting May 13, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1044-2016 on Jun 29, 2016. Reason: Chemical Contamination: Bottles may contain broken dessicants. Status: Terminated.

Why it was recalled

Chemical Contamination: Bottles may contain broken dessicants

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 638J011A

Where it was sold

Nationwide & Puerto Rico.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1044-2016
Classification
Class III
Status
Terminated
Recall initiated
May 13, 2016
FDA report date
Jun 29, 2016
Quantity
24,614 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Virtus Pharmaceuticals, Llc

Original FDA data

Every field from FDA enforcement report D-1044-2016, exactly as published.

Show all FDA fields
City
Tampa
State
FL
Status
Terminated
Country
United States
Event ID
74251
Address
2649 Causeway Center Dr
Code information
Lot #: 638J011A
Postal code
33619-6102
Report date
Jun 29, 2016
Product type
Drugs
Recall number
D-1044-2016
Classification
Class III
Recalling firm
Virtus Pharmaceuticals, Llc
Product quantity
24,614 bottles
Termination date
Aug 21, 2018
Reason for recall
Chemical Contamination: Bottles may contain broken dessicants
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide & Puerto Rico.
Recall initiation date
May 13, 2016
Initial firm notification
E-Mail
Center classification date
Jun 20, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1044-2016, published Jun 29, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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