FDAClass IIIJanuary 19, 2022

Morphine Sulfate Oral Solution 100 mg per recall: Labeling Error

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC…

Why was Morphine Sulfate Oral Solution 100 mg per recalled?

Labeling: Missing Label

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: 375153 Exp. 10/31/2022

Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC…
Recalling firm
Akorn, Inc.
Quantity
10,836 bottles
Distribution
Nationwide USA
Recall date
January 19, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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