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Class II: temporary or reversible health riskTerminated

Actavis Vancomycin Hydrochloride Capsule Recall

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd

Actavis Inc · Parsippany, NJ

Risk level
Class II
Reported by FDA
Nov 5, 2014
Recall ID
D-0232-2015
Check your lot numberHow we source this data

Summary

Actavis recalled Vancomycin Hydrochloride Capsule starting Aug 25, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0232-2015 on Nov 5, 2014. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4

Lot numbers, UPCs & expiration codes

3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, exp Dec 2014

Where it was sold

Nationwide

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-0232-2015
Classification
Class II
Status
Terminated
Recall initiated
Aug 25, 2014
FDA report date
Nov 5, 2014
Quantity
26,663 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Actavis Inc

Original FDA data

Every field from FDA enforcement report D-0232-2015, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
69553
Address
400 Interpace Pkwy
Code information
3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, exp Dec 2014
Postal code
07054-1120
Report date
Nov 5, 2014
Product type
Drugs
Recall number
D-0232-2015
Classification
Class II
Recalling firm
Actavis Inc
Product quantity
26,663 cartons
Termination date
Mar 21, 2018
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
Distribution pattern
Nationwide
Recall initiation date
Aug 25, 2014
Initial firm notification
Letter
Center classification date
Oct 30, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0232-2015, published Nov 5, 2014. 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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