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Class II: temporary or reversible health riskTerminated

Mallinckrodt Hydrocodone Bitartrate and Acetaminophen Recall

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7

Mallinckrodt Inc. · Hobart, NY

Risk level
Class II
Reported by FDA
Aug 8, 2012
Recall ID
D-1431-2012
Check your lot numberHow we source this data

Summary

Mallinckrodt recalled Hydrocodone Bitartrate and Acetaminophen starting May 25, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1431-2012 on Aug 8, 2012. Reason: CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. Status: Terminated.

Why it was recalled

CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.

Product description

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

Lot numbers, UPCs & expiration codes

Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13

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-1431-2012
Classification
Class II
Status
Terminated
Recall initiated
May 25, 2012
FDA report date
Aug 8, 2012
Quantity
44,330 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mallinckrodt Inc.

Original FDA data

Every field from FDA enforcement report D-1431-2012, exactly as published.

Show all FDA fields
City
Hobart
State
NY
Status
Terminated
Country
United States
Event ID
61967
Address
172 Railroad Avenue
Code information
Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13
Postal code
13788-0416
Report date
Aug 8, 2012
Product type
Drugs
Recall number
D-1431-2012
Classification
Class II
Recalling firm
Mallinckrodt Inc.
Product quantity
44,330 bottles
Termination date
Apr 17, 2015
Reason for recall
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Distribution pattern
Nationwide
Recall initiation date
May 25, 2012
Initial firm notification
Letter
Center classification date
Jul 31, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1431-2012, published Aug 8, 2012. 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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