Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC
Summary
The FDA issued a Class II for Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord by Preferred Pharmaceuticals, Inc.. Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection..
Details
Source
Drug Recall
External ID
D-0513-2023
Action Date
2023-04-12
Status
Ongoing
Category
drug
Product Description
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Lot/Code Info: Lot: E0922W, G1222E, I0922W and K3022W Exp 10/31/2023.
Quantity Affected: 72 Bottles
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-23
Company
Anaheim, CA
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 70 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 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 (Preferred Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0513-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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