Dr. Reddy's Recalls Imatinib Mesylate Tablets for Dissolution Failures
Dr. Reddy's Laboratories is recalling specific lots of Imatinib Mesylate 100mg tablets because they failed to meet required dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is voluntarily recalling specific lots of Imatinib Mesylate Tablets 100mg. The recall was initiated because the affected product failed to meet established dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate for absorption in the body.
The recalled product includes 90-count bottles (NDC 43598-344-90) and 30-count institutional cartons (NDC 43598-344-31). The specific lots affected are H2000206 and H2000138, both with an expiration date of 06/22. A total of 1,350 bottles and 147 cartons were distributed nationwide in the USA.
Patients and healthcare providers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for replacement or refund. No adverse health effects have been reported in connection with this recall.
The recalled product
- Product
- IMATINIB (IMATINIB)
- Brand
- IMATINIB
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- 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 (3)
- Lot #: a) H2000206
- Exp 06/22
- b) H2000138
Distribution
Distributed nationwide across the United States.
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