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Class II: temporary or reversible health riskTerminated

Actavis Vancomycin Hydrochloride Capsules Recall

Vancomycin Hydrochloride Capsules, USP, 250 mg

Actavis Inc · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jun 25, 2014
Recall ID
D-1386-2014
Check your lot numberHow we source this data

Summary

Actavis recalled Vancomycin Hydrochloride Capsules starting May 16, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1386-2014 on Jun 25, 2014. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug.

Product description

Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.

Lot numbers, UPCs & expiration codes

Lot #: 3100135, Expiry: 05/2014

Where it was sold

U.S. 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-1386-2014
Classification
Class II
Status
Terminated
Recall initiated
May 16, 2014
FDA report date
Jun 25, 2014
Quantity
6913 packages
Recall type
Voluntary: Firm initiated
Recalling firm
Actavis Inc

Original FDA data

Every field from FDA enforcement report D-1386-2014, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
68453
Address
400 Interpace Pkwy
Code information
Lot #: 3100135, Expiry: 05/2014
Postal code
07054-1120
Report date
Jun 25, 2014
Product type
Drugs
Recall number
D-1386-2014
Classification
Class II
Recalling firm
Actavis Inc
Product quantity
6913 packages
Termination date
Feb 23, 2015
Reason for recall
Subpotent Drug.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
Distribution pattern
U.S. Nationwide
Recall initiation date
May 16, 2014
Initial firm notification
Letter
Center classification date
Jun 17, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1386-2014, published Jun 25, 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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