February 2015 FDA Recall Drug by Qualitest Pharmaceuticals
D-0411-2015 - Presence of Foriegn Substance

This Class II drug recall was voluntarily initiated by Qualitest Pharmaceuticals on February 23, 2015 for the product Drug. The FDA reported the reason for recall as presence of foriegn substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0411-2015

Reason for Recall
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Initiated
02-23-2015
Reported
03-18-2015
Quantity
972 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70598
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.
Qualitest Pharmaceuticals
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.
07-12-2016
Product Description About Product Description
Full technical description of the product.
PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

Batch or Lot Expiration Information

Lot# : 0000001099; Exp. 03/16