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Class III: unlikely to cause harmTerminated

West-ward Pharmaceutical Glycopyrrolate Tablets Recall

Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: We…

West-ward Pharmaceutical Corp. · Eatontown, NJ

Risk level
Class III
Reported by FDA
Feb 20, 2013
Recall ID
D-164-2013
Check your lot numberHow we source this data

Summary

West-ward Pharmaceutical recalled Glycopyrrolate Tablets starting Jan 7, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-164-2013 on Feb 20, 2013. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.

Lot numbers, UPCs & expiration codes

Lot #: 69001A

Where it was sold

OH

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-164-2013
Classification
Class III
Status
Terminated
Recall initiated
Jan 7, 2013
FDA report date
Feb 20, 2013
Quantity
1,185 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
West-ward Pharmaceutical Corp.

Original FDA data

Every field from FDA enforcement report D-164-2013, exactly as published.

Show all FDA fields
City
Eatontown
State
NJ
Status
Terminated
Country
United States
Event ID
64108
Address
465 Industrial Way W
Code information
Lot #: 69001A
Postal code
07724-2209
Report date
Feb 20, 2013
Product type
Drugs
Recall number
D-164-2013
Classification
Class III
Recalling firm
West-ward Pharmaceutical Corp.
Product quantity
1,185 Bottles
Termination date
May 16, 2014
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
Distribution pattern
OH
Recall initiation date
Jan 7, 2013
Initial firm notification
Letter
Center classification date
Feb 12, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-164-2013, published Feb 20, 2013. 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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