The Recall Desk
ModerateFDA (Drugs)·D-1256-2014·Announced 2014-04-30

Ohm Laboratories Recalls Loratadine and Pseudoephedrine Sulfate Tablets Due to Blister Defects

Ohm Laboratories is recalling 29,790 blister packs of Loratadine and Pseudoephedrine Sulfate Extended Release Tablets due to unacceptable blister defects.

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 due to packaging defects (blister defects) which are typically associated with minor labeling or packaging issues that may cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria.

Plain-English summary

Ohm Laboratories, Inc. is recalling 29,790 blister packs of Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. The recall was initiated because an unacceptable level of blister defects was identified in the product.

The affected product is distributed under various brand names, including CVS Allergy Relief - D, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid. The specific lots involved are # 2554936 and # 2554938, with an expiration date of 09/15. The product was distributed in California, Ohio, Pennsylvania, Rhode Island, and Texas.

Consumers who have purchased these specific lots should stop using the product and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
Brand
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Affected units
29,790

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 (3)

  • Lot # 2554936
  • 2554938
  • Exp 09/15

UPCs (3)

  • 050428049631
  • 093351116285
  • 011822331555

Distribution

Distributed in 4 states:

Same brand · LORATADINE AND PSEUDOEPHEDRINE SULFATE