Class I · High risk
Thyroid Tablets
Superpotent Drug
Levothyroxine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent; 15 month stability (by mfr)
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00
Affected NDC
54868-4507-00
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
- Recalling firm
- Physicians Total Care, Inc.
- NDC code
- 54868-4507-00
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-214-2013 · 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 Physicians Total Care, Inc.
All 2012 recalls
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
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