June 2019 FDA Recall Drug by Preferred Pharmaceuticals, Inc
D-1410-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on June 10, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distribution was made to CA and FL. and the recall is currently terminated.

Recall Number: D-1410-2019

Reason for Recall
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
06-10-2019
Reported
06-26-2019
Quantity
192 4 oz bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83101
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made to CA and FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2023
Product Description About Product Description
Full technical description of the product.
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

Batch or Lot Expiration Information

Lot# Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020