March 2014 FDA Recall Drug by Paddock Laboratories, Llc
D-1168-2014 - Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.

This Class II drug recall was voluntarily initiated by Paddock Laboratories, Llc on March 11, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter perrigo is recalling seven lots of clindamycin palmitate hydrochloride for oral solution 75mg/5ml.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1168-2014

Reason for Recall
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
Initiated
03-11-2014
Reported
03-26-2014
Quantity
156,012 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67735
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.
Paddock Laboratories, LLC
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.
09-18-2014
Product Description About Product Description
Full technical description of the product.
Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01

Batch or Lot Expiration Information

Lot# 2013313915 Exp 08/15, 2013374398 Exp 09/15, 2013323969 Exp 08/15, 2013364336 Exp 09/15, 2013323971 Exp 08/15, 2013364334 Exp 09/15, 2013313913 Exp 08/15