Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0854
Summary
The FDA issued a Class II for Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macl by Macleods Pharmaceuticals Ltd. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0154-2025
Action Date
2024-12-25
Status
Ongoing
Category
drug
Product Description
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Lot/Code Info: Lot# BOB12318A Exp 07/31/2027
Quantity Affected: 15,744 30-count bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-25
Company
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 75 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Macleods Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 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 Pharmaceuticals Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macleods Pharmaceuticals Ltd have FDA actions?
Macleods Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0154-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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