Class I · High risk
Thyroid Tablets
Superpotent Drug
Liothyronine Sodium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
Affected NDCs
42794-0018-02
42794-0018-06
Compare with the code on your package — it is the most precise check available.
Drug: Liothyronine Category: Thyroid Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Liothyronine Sodium NDC 42794-0018 |
5 ug/1 | Tablet Oral |
Sigmapharm Laboratories, LLC | Rx |
- Recalling firm
- SigmaPharm Laboratories LLC
- NDC code
- 42794-018-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1344-2014 · 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 Liothyronine recalls
See all
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Nature-Throid 1 GR
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Other recalls by SigmaPharm Laboratories LLC
All 2014 recalls
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
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