The Recall Desk
LowFDA (Drugs)·D-0034-2016·Announced 2015-10-21

Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay

Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

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 classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Ohm Laboratories, Inc. is recalling Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 33,984 boxes of the medication, which are distributed nationwide. The affected products are packaged in 10-count and 30-count boxes and are distributed by Safeway Inc.

The recall was initiated because the medication produced an out-of-specification (OOS) result for assay, indicating that the drug's potency did not meet required standards. This is classified as a superpotent drug issue. Specific batch numbers and expiration dates are listed in the official recall documentation.

Consumers who have these products should stop using them and return them to the point of purchase or contact the recalling firm for further instructions. The FDA has classified this recall as Class III, meaning it is unlikely to cause adverse health consequences.

The recalled product

Product
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
33,984

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 (9)

  • Batch Numbers: a) 2658140
  • Exp 11/30/2016
  • 2625092
  • Exp 6/30/2016
  • 2617893
  • Exp 5/31/2016
  • b) 2625092
  • 2644265
  • Exp 9/30/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Ohm Laboratories, 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 21 products in this recall →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

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Same hazard · potency failure

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