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Class II: temporary or reversible health riskTerminated

West-ward Belladonna Alkaloids with Recall

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 01…

West-Ward Pharmaceutical Corp. · Eatontown, NJ

Risk level
Class II
Reported by FDA
Jul 31, 2013
Recall ID
D-825-2013
Check your lot numberHow we source this data

Summary

West-Ward Pharmaceutical recalled West-ward Belladonna Alkaloids with starting May 16, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-825-2013 on Jul 31, 2013. Reason: Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol. Status: Terminated.

Why it was recalled

Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.

Product description

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

Lot numbers, UPCs & expiration codes

Lot# 67331A, Exp 10/14

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-825-2013
Classification
Class II
Status
Terminated
Recall initiated
May 16, 2013
FDA report date
Jul 31, 2013
Quantity
7,324 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
West-Ward Pharmaceutical Corp.

Original FDA data

Every field from FDA enforcement report D-825-2013, exactly as published.

Show all FDA fields
City
Eatontown
State
NJ
Status
Terminated
Country
United States
Event ID
65445
Address
465 Industrial Way W
Code information
Lot# 67331A, Exp 10/14
Postal code
07724-2209
Report date
Jul 31, 2013
Product type
Drugs
Recall number
D-825-2013
Classification
Class II
Recalling firm
West-Ward Pharmaceutical Corp.
Product quantity
7,324 bottles
Termination date
Jun 23, 2014
Reason for recall
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Voluntary / mandated
Voluntary: Firm initiated
Product description
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Distribution pattern
Nationwide
Recall initiation date
May 16, 2013
Initial firm notification
Letter
Center classification date
Jul 25, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-825-2013, published Jul 31, 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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