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Class III: unlikely to cause harmTerminated

L. Perrigo Liothyronine Sodium Tablets Recall

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Pad…

L. Perrigo Co. · Allegan, MI

Risk level
Class III
Reported by FDA
May 15, 2013
Recall ID
D-318-2013
Check your lot numberHow we source this data

Summary

L. Perrigo recalled Liothyronine Sodium Tablets starting Mar 12, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-318-2013 on May 15, 2013. Reason: Failed Impurities/Degradation Specifications: 3 month stability testing. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: 3 month stability testing.

Product description

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,

Lot numbers, UPCs & expiration codes

12K714 exp. 12/13, 12K715 exp. 12/13

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-318-2013
Classification
Class III
Status
Terminated
Recall initiated
Mar 12, 2013
FDA report date
May 15, 2013
Quantity
21,667 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
L. Perrigo Co.

Original FDA data

Every field from FDA enforcement report D-318-2013, exactly as published.

Show all FDA fields
City
Allegan
State
MI
Status
Terminated
Country
United States
Event ID
64729
Address
515 Eastern Ave
Code information
12K714 exp. 12/13, 12K715 exp. 12/13
Postal code
49010-9070
Report date
May 15, 2013
Product type
Drugs
Recall number
D-318-2013
Classification
Class III
Recalling firm
L. Perrigo Co.
Product quantity
21,667 bottles
Termination date
Jul 24, 2013
Reason for recall
Failed Impurities/Degradation Specifications: 3 month stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Distribution pattern
Nationwide
Recall initiation date
Mar 12, 2013
Initial firm notification
Letter
Center classification date
May 9, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-318-2013, published May 15, 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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