FDAClass IIApril 10, 2019

Morphine Sulfate USP Milled recall: Sterility Concern

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ…

Why was Morphine Sulfate USP Milled recalled?

Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# B1414-160809, Retest Date AUG 2021

Product
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ…
Recalling firm
Johnson Matthey Inc.
Quantity
169.976 kg
Distribution
Nationwide in the US
Recall date
April 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls