D-0028-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 29, 2014
- Initiation Date
- July 16, 2014
- Termination Date
- August 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,739 bottles
Product Description
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
Reason for Recall
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
Distribution Pattern
Nationwide
Code Information
Lot 3L20, Exp. 11/15