May 2015 FDA Recall Drug by Ohm Laboratories, Inc.
D-1142-2015 - Superpotent Drug

This Class III drug recall was voluntarily initiated by Ohm Laboratories, Inc. on May 4, 2015 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1142-2015

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
05-04-2015
Reported
06-24-2015
Quantity
2592 Blister Packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71334
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2016
Product Description About Product Description
Full technical description of the product.
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)

Batch or Lot Expiration Information

Lot# : 2625094, Exp 06/2016