Key Takeaway

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 by King Legacy, a wholly owned subsidiary of Pfizer was recalled on April 30, 2013. The hazard: Subpotent Drug: The products were below specification for potency at the expiry stability point.

FDA Drug Class II Terminated

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

Recalled: April 30, 2013 ~56,405 bottles units affected D-429-2013

Description

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

King Legacy, a wholly owned subsidiary of Pfizer

Bristol, TN, United States

View all 11 recalls by King Legacy, a wholly owned subsidiary of Pfizer →

Distribution

Nationwide and Puerto Rico

Related Recalls

Frequently Asked Questions

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What remedy is available for this recall?

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