December 2015 FDA Recall Drug by Bio-pharm, Inc.
D-0809-2016 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Bio-pharm, Inc. on December 17, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0809-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Initiated
12-17-2015
Reported
04-13-2016
Quantity
103,664 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72819
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.
Bio-pharm, 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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-08-2017
Product Description About Product Description
Full technical description of the product.
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

Batch or Lot Expiration Information

Lot# s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017