Status
Terminated
Drug Enforcement D-424-2013
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Classification
Class II
Report Date
May 29, 2013
Termination Date
June 30, 2016
Product Information
- Product description
- Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
- Product quantity
- 112,914 bottles
- Reason for recall
- Subpotent Drug: The products were below specification for potency at the expiry stability point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer
- Address
-
501 5th Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-424-2013
- Event ID
- 65172
- Recall initiation date
- April 30, 2013
- Center classification date
- May 20, 2013
- Code info
- Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13
- More code info
- —