FDA-Drug2013-05-29Class II

Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

King Legacy, a wholly owned subsidiary of Pfizer
Hazard

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Sold states
Nationwide and Puerto Rico
Affected count
56,405 bottles
Manufactured in
501 5th Street, N/A, Bristol, TN, United States
Products
Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-429-2013

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