June 2023 FDA Recall Drug by The Harvard Drug Group
D-0878-2023 - Packaging defect

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on June 16, 2023 for the product Drug. The FDA reported the reason for recall as packaging defect. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0878-2023

Reason for Recall
Packaging defect: blister packaging inadequately sealed.
Initiated
06-16-2023
Reported
07-05-2023
Quantity
3876 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92524
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.
The Harvard Drug Group
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 in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2024
Product Description About Product Description
Full technical description of the product.
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

Batch or Lot Expiration Information

Lot# : M04343, Exp. 04/2024