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Class II: temporary or reversible health riskTerminated

Aidapak Services LEVOTHYROXINE/ LIOTHYRONINE Tablet Recall

LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4

Aidapak Services, LLC · Vancouver, WA

Risk level
Class II
Reported by FDA
Jan 22, 2014
Recall ID
D-555-2014
Check your lot numberHow we source this data

Summary

Aidapak Services recalled LEVOTHYROXINE/ LIOTHYRONINE Tablet starting Jul 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-555-2014 on Jan 22, 2014. Reason: Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014. Status: Terminated.

Why it was recalled

Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.

Product description

LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901

Lot numbers, UPCs & expiration codes

LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19, EXP: 3/31/2014.

Where it was sold

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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-555-2014
Classification
Class II
Status
Terminated
Recall initiated
Jul 2, 2013
FDA report date
Jan 22, 2014
Quantity
102 Tablets
Recall type
Voluntary: Firm initiated
Recalling firm
Aidapak Services, LLC

Original FDA data

Every field from FDA enforcement report D-555-2014, exactly as published.

Show all FDA fields
City
Vancouver
State
WA
Status
Terminated
Country
United States
Event ID
65707
Address
14301 Se 1st St
Code information
LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19, EXP: 3/31/2014.
Postal code
98684-3501
Report date
Jan 22, 2014
Product type
Drugs
Recall number
D-555-2014
Classification
Class II
Recalling firm
Aidapak Services, LLC
Product quantity
102 Tablets
Termination date
Feb 7, 2014
Reason for recall
Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.
Voluntary / mandated
Voluntary: Firm initiated
Product description
LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall initiation date
Jul 2, 2013
Initial firm notification
Telephone
Center classification date
Jan 16, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-555-2014, published Jan 22, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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