Class I · High risk
Thyroid Tablets
Superpotent Drug
Levothroid
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; does not meet in process specification requirements
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.
What was recalled
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Affected NDC
0456-1328-01
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
- Recalling firm
- Lloyd Inc. of Iowa
- NDC code
- 0456-1328-01
- Origin
- IA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-085-2013 · FDA notice
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.
Other Levothyroxine recalls
See all
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other recalls by Lloyd Inc. of Iowa
All 2012 recalls
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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