Drug & medication recalls

Johnson Matthey Inc. recalls Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass co…

Recall date
April 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1252-2019
FDA classification
Class III
Brand / firm
Johnson Matthey Inc.
Sold / distributed
Product was distributed to one manufacturer in Morgantown, WV who may have manufactured the product into finished product and further distribute to the retail level Nationwide in the USA.

Why it was recalled

Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.

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