Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-25
Summary
The FDA issued a Class II for Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534 by RemedyRepack Inc.. Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity cha.
Details
Source
Drug Recall
External ID
D-0578-2023
Action Date
2023-05-24
Status
Ongoing
Category
drug
Product Description
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
Lot/Code Info: Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
Quantity Affected: 29 x 30-count card, 1 x 100 UD box
Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Distribution
Product was distrituded to three direct account in PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-01
Company
Indiana, PA
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 99 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RemedyRepack Inc. has 34 FDA actions in our database, including 34 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 (RemedyRepack Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RemedyRepack Inc. have FDA actions?
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0578-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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