Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Drugs Recalls
Prescription and over-the-counter medications
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.