Why it was recalled
Superpotent
Product description
LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
Lot numbers, UPCs & expiration codes
16H21, Exp. 08/2017
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-0150-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 2,666 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0150-2017, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 75691
- Address
- 235 East 42nd Street
- Code information
- 16H21, Exp. 08/2017
- Postal code
- 10017-5703
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0150-2017
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 2,666 bottles
- Termination date
- May 1, 2020
- Reason for recall
- Superpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 7, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2016