The Recall Desk
ModerateFDA (Drugs)·D-1344-2014·Announced 2014-05-28

SigmaPharm Recalls Liothyronine Sodium Tablets Due to Cross-Contamination

SigmaPharm is recalling four lots of Liothyronine Sodium Tablets 5 mcg due to potential cross-contamination with trace amounts of a previously manufactured product.

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 the source text describes a potential carryover of trace amounts without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

SigmaPharm Laboratories LLC is recalling four lots of Liothyronine Sodium Tablets, USP 5 mcg. The recall was initiated because of the finding of a potential carryover of trace amounts of a previously manufactured product.

The affected product is a prescription-only medication available in 100-count bottles (NDC 42794-018-02) and 1000-count bottles (NDC 42794-018-06). The specific lots involved are 1302201 (Exp 01/2015), 1305501 (Exp 03/2015), 1314801 (Exp 10/2015), and 1302202 (Exp 01/2015). A total of 43,007 bottles were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
Brand
LIOTHYRONINE SODIUM
Manufacturer
SigmaPharm Laboratories LLC
Category
Drug — Prescription Drug
Hazard
Affected units
43,007

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 (7)

  • Lot #s: a) 1302201
  • Exp 01/2015
  • 1305501
  • Exp 03/2015
  • 1314801
  • Exp 10/2015
  • b) 1302202

UPCs (3)

  • 0342794018121
  • 0342794019128
  • 0342794020124

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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