The Recall Desk
LowFDA (Drugs)·D-318-2013·Announced 2013-05-15

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.

What this means for you

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.

Related recalls

Same manufacturer · L. Perrigo Co.

See all →

Same hazard · stability failure

See all →