Status
Terminated
Drug Enforcement D-426-2013
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, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
- Product quantity
- 107,236 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-426-2013
- Event ID
- 65172
- Recall initiation date
- April 30, 2013
- Center classification date
- May 20, 2013
- Code info
- Lot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13
- More code info
- —