Macleods Recalls Olanzapine Tablets Due to Impurity Levels
Macleods Pharmaceuticals is recalling Olanzapine 5 mg tablets because organic and unspecified impurities exceeded specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Macleods Pharmaceuticals Limited is recalling Olanzapine Tablets, USP 5 mg, 30-count bottles. The recall involves 22,032 bottles of the medication, which is a prescription-only atypical antipsychotic manufactured in India and distributed nationwide in the USA.
The recall was initiated because the product failed impurities and degradation specifications, specifically due to organic and unspecified impurities being above the allowed limits. The affected product is identified by Lot BOB22321A with an expiration date of 07-31-2027.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- OLANZAPINE (OLANZAPINE)
- Brand
- OLANZAPINE
- Manufacturer
- Macleods Pharmaceuticals Limited
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: BOB22321A
- Exp 07-31-2027.
UPCs (6)
- 0333342067074
- 0333342070074
- 0333342069078
- 0333342072078
- 0333342071071
- 0333342068071
Distribution
Distributed nationwide across the United States.
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