Why it was recalled
Subpotent; 15 month stability
Product description
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Lot numbers, UPCs & expiration codes
11T7011A, Exp. Date: 12/2012
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-104-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2012
- FDA report date
- Jan 2, 2013
- Quantity
- 7,432 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alara Pharmaceutical Co
Original FDA data
Every field from FDA enforcement report D-104-2013, exactly as published.
Show all FDA fields
- City
- San Juan
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 63608
- Address
- 270 Ave Munoz Rivera #301
- Code information
- 11T7011A, Exp. Date: 12/2012
- Postal code
- 00918
- Report date
- Jan 2, 2013
- Product type
- Drugs
- Recall number
- D-104-2013
- Classification
- Class II
- Recalling firm
- Alara Pharmaceutical Co
- Product quantity
- 7,432 bottles
- Termination date
- Jan 3, 2014
- Reason for recall
- Subpotent; 15 month stability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 29, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 21, 2012