Recall
FDAHealthNovember 25, 2024

Macleods Pharmaceuticals Ltd — 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. Pri

⚠️ Failed Impurities/Degradation Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 25, 2024

Nationwide in the USA

What's affected?

Product
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.
UPC
0333342067074
Lot code
BOB12318A

Additional details

Lot# BOB12318A Exp 07/31/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 15,744 30-count bottles.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.