Johnson Matthey Recalls Cisplatin Active Pharmaceutical Ingredient Due to Glass Contamination
Johnson Matthey Inc. is recalling 26,625 grams of Cisplatin Active Pharmaceutical Ingredient due to potential glass contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Johnson Matthey Inc. is recalling 26,625 grams of Cisplatin Active Pharmaceutical Ingredient. The product was distributed nationwide within the United States. The specific lot affected is B0101-161102, with an expiration date of December 2021.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations that resulted in potential glass contamination. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected lot of Cisplatin Active Pharmaceutical Ingredient and contact Johnson Matthey Inc. for further instructions or a refund.
The recalled product
- Product
- Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
- 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 (2)
- Lot #: B0101-161102
- Exp. Dec 2021
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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