Liothyronine Sodium Tablets Recalled for Failed Stability Testing
L. Perrigo Co. is recalling Liothyronine Sodium Tablets, 5 mcg, because they failed 3-month stability testing specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
L. Perrigo Co. is recalling Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles. The product is distributed by Paddock Laboratories, Inc., in Minneapolis, MN, and carries the NDC 0574-0220-01. The recall involves 21,667 bottles distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications during 3-month stability testing. The affected lots are 12K714 and 12K715, both with an expiration date of 12/13.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on replacement or disposal. The FDA classifies this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
- Manufacturer
- L. Perrigo Co.
- Category
- Drug — Thyroid Hormone
- Hazard
- Affected units
- 21,667
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 12K714 exp. 12/13
- 12K715 exp. 12/13
Distribution
Distributed nationwide across the United States.
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