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
Failed Dissolution Specifications.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
Affected NDC
0574-0222-01
Compare with the code on your package — it is the most precise check available.
Drug: Liothyronine Category: Thyroid Medication
- Recalling firm
- Mayne Pharma Inc
- NDC code
- 0574-0222-01
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0098-2018 · 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 Mayne Pharma Inc
All 2017 recalls
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk
Lexette (halobetasol propionate)
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
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