The Recall Desk
LowFDA (Drugs)·D-0037-2016·Announced 2015-10-21

Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results

Ohm Laboratories is recalling Sunmark loratadine 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 is defined as a situation unlikely to cause adverse health consequences. The hazard is a potency deviation without reported injuries.

Plain-English summary

Ohm Laboratories, Inc. is recalling Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 10-count and 30-count boxes distributed by McKesson. The specific products are identified by NDC 49348-930-01 and NDC 49348-930-44.

The recall was initiated because the products produced an out-of-specification (OOS) result for Assay, which indicates the drug potency did not meet required standards. The affected batch numbers are 2544488, 26917891, 2617893, and 2644273, with expiration dates ranging from May 31, 2016, to September 30, 2016.

The products were distributed nationwide. Consumers should stop using the affected tablets and return them to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard

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 (8)

  • Batch Numbers: (a) 2544488
  • Exp 7/31/2016
  • 26917891
  • Exp 5/31/2016. (b) 2544488
  • 2617893
  • Exp 5/31/2016
  • 2644273
  • 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 deviation

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