Fentanyl Citrate Ingredient Recalled for Potential Glass Contamination
Johnson Matthey Inc. is recalling fentanyl citrate active pharmaceutical ingredient due to potential glass contamination.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is potential glass contamination, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Johnson Matthey Inc. is recalling 52,882.23 grams of Fentanyl Citrate Active Pharmaceutical Ingredient. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential glass contamination.
The affected product includes lots B0030-180101 and B0030-180102, which have an expiration date of February 2023. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected lots and contact Johnson Matthey Inc. for further instructions or a return.
The recalled product
- Product
- Fentanyl Citrate 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 (3)
- Lot #: B0030-180101
- B0030-180102
- Exp. Feb 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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