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Class III: unlikely to cause harmTerminated

Ohm Laboratories Meijer Loratadine Orally Disintegrating Recall

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box,…

Ohm Laboratories, Inc. · North Brunswick, NJ

Risk level
Class III
Reported by FDA
Oct 21, 2015
Recall ID
D-0039-2016
Check your lot numberHow we source this data

Summary

Ohm Laboratories recalled Meijer Loratadine Orally Disintegrating starting Jul 28, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0039-2016 on Oct 21, 2015. Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay. Status: Terminated.

Why it was recalled

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Product description

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8

Lot numbers, UPCs & expiration codes

Batch Number: 2610783, Exp 4/30/2016

Where it was sold

Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0039-2016
Classification
Class III
Status
Terminated
Recall initiated
Jul 28, 2015
FDA report date
Oct 21, 2015
Quantity
5,040 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Ohm Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0039-2016, exactly as published.

Show all FDA fields
City
North Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
71973
Address
1385 Livingston Ave
Code information
Batch Number: 2610783, Exp 4/30/2016
Postal code
08902-1829
Report date
Oct 21, 2015
Product type
Drugs
Recall number
D-0039-2016
Classification
Class III
Recalling firm
Ohm Laboratories, Inc.
Product quantity
5,040 boxes
Termination date
Oct 28, 2016
Reason for recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
Distribution pattern
Nationwide.
Recall initiation date
Jul 28, 2015
Initial firm notification
Letter
Center classification date
Oct 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0039-2016, published Oct 21, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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