The Recall Desk
ModerateFDA (Drugs)·D-0183-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Liothyronine SR Capsules Due to Labeling Errors

KRS Global Biotechnology is recalling Liothyronine SR 20 mcg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling Liothyronine SR (T3) 20 mcg Capsules, a prescription-only medication. The recall is due to a labeling issue where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.

The affected product is distributed nationwide in the USA, Bermuda, and New Zealand. The recall involves 970 capsules from specific lots: 05022017@24 (BUD: 4/27/2018), 10122017@21 (BUD: 4/10/2018), 11062017@38 (BUD: 5/5/2018), and 08252017@28 (BUD: 8/20/2018).

Consumers and healthcare providers should stop using the affected capsules and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Affected units
970

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 (4)

  • Lots: 05022017@24 BUD: 4/27/2018
  • 10122017@21 BUD: 4/10/2018
  • 11062017@38 BUD: 5/5/2018
  • 08252017@28 BUD: 8/20/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 47 products in this recall →