Morphine Sulfate API Recalled for Microbial Contamination Out of Specification
Johnson Matthey Inc. is recalling Morphine Sulfate USP Milled API due to bioburden out of specification results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen or contamination issue (microbial/bioburden) in a pharmaceutical ingredient without reported illness, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Johnson Matthey Inc. is recalling Morphine Sulfate USP Milled, an Active Pharmaceutical Ingredient (API) intended for prescription use only. The recall is being conducted because the product failed to meet specifications for microbial contamination, specifically showing bioburden out of specification results.
The affected product is Lot# B1414-160809 with a retest date of AUG 2021. The total quantity involved in the recall is 169.976 kg. The product was distributed nationwide in the US.
Consumers and healthcare providers should stop using the affected lot and contact their supplier or the recalling firm for further instructions. This recall involves a non-sterile product where the microbial load exceeded acceptable limits.
The recalled product
- Product
- Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
- Manufacturer
- Johnson Matthey Inc.
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# B1414-160809
- Retest Date AUG 2021
Distribution
Distributed nationwide across the United States.
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