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Class III: unlikely to cause harmTerminated

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Nicorette Lozenge and NicoDerm CQ Recall

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Aiken, SC

Risk level
Class III
Reported by FDA
Apr 30, 2014
Recall ID
D-1247-2014
Check your lot numberHow we source this data

Summary

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline recalled Nicorette Lozenge and NicoDerm CQ starting Feb 20, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1247-2014 on Apr 30, 2014. Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Status: Terminated.

Why it was recalled

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Product description

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.

Lot numbers, UPCs & expiration codes

Lot #13L05N, Expiry: 8/15

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-1247-2014
Classification
Class III
Status
Terminated
Recall initiated
Feb 20, 2014
FDA report date
Apr 30, 2014
Quantity
150 cases
Recall type
Voluntary: Firm initiated
Recalling firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Original FDA data

Every field from FDA enforcement report D-1247-2014, exactly as published.

Show all FDA fields
City
Aiken
State
SC
Status
Terminated
Country
United States
Event ID
67800
Address
65 Windham Blvd
Code information
Lot #13L05N, Expiry: 8/15
Postal code
29805-9384
Report date
Apr 30, 2014
Product type
Drugs
Recall number
D-1247-2014
Classification
Class III
Recalling firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Product quantity
150 cases
Termination date
Jan 20, 2017
Reason for recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.
Distribution pattern
U.S. Nationwide
Recall initiation date
Feb 20, 2014
Initial firm notification
Letter
Center classification date
Apr 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1247-2014, published Apr 30, 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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