March 2018 FDA Recall Drug by Lake Erie Medical & Surgical Supply Inc
D-0626-2018 - Labeling

This Class III drug recall was voluntarily initiated by Lake Erie Medical & Surgical Supply Inc on March 19, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in FL, VA and the recall is currently terminated.

Recall Number: D-0626-2018

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
03-19-2018
Reported
04-18-2018
Quantity
16 paper cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79640
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.
Lake Erie Medical & Surgical Supply 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-03-2020
Product Description About Product Description
Full technical description of the product.
Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01

Batch or Lot Expiration Information

Lot# 116289, Exp. 09/20