Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08
Summary
The FDA issued a Class II for Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macl by Macleods Pharma Usa Inc. Reason: cGmp Deviations.
Details
Source
Drug Recall
External ID
D-0639-2022
Action Date
2022-03-09
Status
Terminated
Category
drug
Product Description
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
Lot/Code Info: Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
Quantity Affected: 3672 bottles
Reason for Recall
cGmp Deviations
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-16
Company
Plainsboro, NJ
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 80 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Macleods Pharma Usa Inc has 18 FDA actions in our database, including 18 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 (Macleods Pharma Usa Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macleods Pharma Usa Inc have FDA actions?
Macleods Pharma Usa Inc has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0639-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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