Why it was recalled
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Product description
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Lot numbers, UPCs & expiration codes
Lot # HE02221, Exp. 05/2023
Where it was sold
Nationwide and Puerto Rico.
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-0353-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 6, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 21,276 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-0353-2023, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91654
- Address
- 44 Whippany Rd Ste 107
- Code information
- Lot # HE02221, Exp. 05/2023
- Postal code
- 07960-4558
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0353-2023
- Classification
- Class II
- Recalling firm
- Alvogen, Inc
- Product quantity
- 21,276 bottles
- Termination date
- Mar 18, 2024
- Reason for recall
- Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Feb 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 24, 2023