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Class II: temporary or reversible health riskTerminated

Core Pharma Pyridostigmine Bromide Tablets 60 mg Recall

Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distrib…

Core Pharma Llc · Middlesex, NJ

Risk level
Class II
Reported by FDA
Oct 2, 2013
Recall ID
D-1062-2013
Check your lot numberHow we source this data

Summary

Core Pharma recalled Pyridostigmine Bromide Tablets 60 mg starting Jul 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1062-2013 on Oct 2, 2013. Reason: Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing. Status: Terminated.

Why it was recalled

Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.

Product description

Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10

Lot numbers, UPCs & expiration codes

109497; Exp. 12/15

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-1062-2013
Classification
Class II
Status
Terminated
Recall initiated
Jul 2, 2013
FDA report date
Oct 2, 2013
Quantity
960 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Core Pharma Llc

Original FDA data

Every field from FDA enforcement report D-1062-2013, exactly as published.

Show all FDA fields
City
Middlesex
State
NJ
Status
Terminated
Country
United States
Event ID
65889
Address
215 Wood Ave
Code information
109497; Exp. 12/15
Postal code
08846-2554
Report date
Oct 2, 2013
Product type
Drugs
Recall number
D-1062-2013
Classification
Class II
Recalling firm
Core Pharma Llc
Product quantity
960 bottles
Termination date
Aug 25, 2014
Reason for recall
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Distribution pattern
Nationwide
Recall initiation date
Jul 2, 2013
Initial firm notification
Letter
Center classification date
Sep 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1062-2013, published Oct 2, 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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