Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Indu
Summary
The FDA issued a Class II for Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, by The Harvard Drug Group. Reason: Packaging defect: blister packaging inadequately sealed..
Details
Source
Drug Recall
External ID
D-0878-2023
Action Date
2023-07-05
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: M04343, Exp. 04/2024
Quantity Affected: 3876 cartons
Reason for Recall
Packaging defect: blister packaging inadequately sealed.
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-16
Company
La Vergne, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Harvard Drug Group) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group have FDA actions?
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0878-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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