FDA Recalls Oxaliplatin Active Pharmaceutical Ingredient Due to Glass Contamination
Johnson Matthey Inc. is recalling Oxaliplatin Active Pharmaceutical Ingredient due to potential glass contamination. The product was distributed nationwide in the United States.
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 potential glass contamination, which is a physical hazard but no injuries or illnesses are reported in the source text, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Oxaliplatin Active Pharmaceutical Ingredient manufactured by Johnson Matthey Inc. The recall is due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential glass contamination of the product.
The affected product is identified by NDC 49821-0075-XX. Specific lots involved in the recall include B0126-170701, B0126-170802 (expiration September 2022), B0126-180401 (expiration May 2023), B0126-180702, and B0126-180803 (expiration October 2023). The total quantity recalled is 316,703.32 units.
The product was distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and returned to the supplier or disposed of according to local regulations. No specific instructions for end-users are provided in the source text beyond the identification of the affected lots.
The recalled product
- Product
- Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
- Manufacturer
- Johnson Matthey Inc.
- 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 (8)
- Lot #: B0126-170701
- B0126-170802
- Exp. Sep 2022
- B0126-180401
- Exp. May 2023
- B0126-180702
- B0126-180803
- Exp. Oct 2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Johnson Matthey Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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