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Class III: unlikely to cause harmTerminated

Legacy Pharmaceutical Packaging Lorazepam Recall

Lorazepam, 0

Legacy Pharmaceutical Packaging LLC · Earth City, MO

Risk level
Class III
Reported by FDA
Jun 12, 2013
Recall ID
D-580-2013
Check your lot numberHow we source this data

Summary

Legacy Pharmaceutical Packaging recalled Lorazepam starting Mar 27, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-580-2013 on Jun 12, 2013. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009

Product description

Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60

Lot numbers, UPCs & expiration codes

L-04009 Exp.11/15

Where it was sold

Distribution was made to IN.

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-580-2013
Classification
Class III
Status
Terminated
Recall initiated
Mar 27, 2013
FDA report date
Jun 12, 2013
Quantity
1,644 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Legacy Pharmaceutical Packaging LLC

Original FDA data

Every field from FDA enforcement report D-580-2013, exactly as published.

Show all FDA fields
City
Earth City
State
MO
Status
Terminated
Country
United States
Event ID
64794
Address
13480 Lakefront Dr
Code information
L-04009 Exp.11/15
Postal code
63045-1516
Report date
Jun 12, 2013
Product type
Drugs
Recall number
D-580-2013
Classification
Class III
Recalling firm
Legacy Pharmaceutical Packaging LLC
Product quantity
1,644 bottles
Termination date
Feb 13, 2014
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Distribution pattern
Distribution was made to IN.
Recall initiation date
Mar 27, 2013
Initial firm notification
Letter
Center classification date
Jun 6, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-580-2013, published Jun 12, 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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