Thyroid Tablets
Superpotent Drug
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Processing Control
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Drug: Liothyronine Category: Thyroid Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Superpotent Drug
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
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