The Recall Desk
LowFDA (Drugs)·D-0038-2016·Announced 2015-10-21

Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues

Ohm Laboratories is recalling Wal-itin Loratadine Orally Disintegrating Tablets because they failed potency testing. The FDA classified this as a Class III recall.

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Ohm Laboratories, Inc. is recalling Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 329,748 boxes of the medication, which are distributed nationwide by Walgreen Co. The product is available in 10-count and 30-count boxes.

The recall was initiated because the tablets produced an out-of-specification (OOS) result for assay, meaning they did not meet the required potency standards. The FDA has classified this recall as Class III, which indicates that the violation is not likely to cause adverse health consequences.

Consumers who have these specific products should stop using them and contact their pharmacist or the recalling firm for instructions on how to return the medication. The affected batch numbers and expiration dates are listed in the official recall documentation.

The recalled product

Product
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
329,748

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 (20)

  • Batch Numbers: a) 2625093
  • Exp 6/30/2016
  • 2617893
  • Exp 5/31/2016
  • 2658137
  • 2658140
  • Exp 11/30/2016
  • 2644265
  • Exp 9/30/2016 b) 2544486
  • 2544487
  • 2544488
  • Exp 7/31/2016
  • 2600125
  • 2600126
  • 2600127
  • Exp 2/29/2016
  • 2644272
  • 2644273
  • Exp 9/30/2016
  • 2625092

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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