Morphine Sulfate Extended - Release Tablets, 30 mg and 60 mg by Bryant Ranch Prepack: Recall - Due to Label-Mix Up

Date:6/30/2022

Official Message No.:111395-6-30-2022-RECL

Contact Info: Eric | eric.lieberman@doh.nj.gov

William | william.manley@doh.nj.gov

Attachments: No

ISSUE: Bryant Ranch Prepack is recalling one lot of Morphine Sulfate Extended- Release Tablets, 30 mg and one lot of Morphine Sulfate Extended Release Tablets, 60 mg because the products have been found to have incorrect labeling where bottles labeled as Morphine Sulfate Extended-Release Tablets, 60 mg contain Morphine Sulfate Extended-Release Tablets, 30 mg and bottles labeled as Morphine Sulfate Extended-Release Tablets, 30 mg may contain Morphine Sulfate Extended-Release Tablets, 60mg. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with "RD" and "71" on one side and plain on the other side. The 60 mg tablets are round, light orange-colored, film-coated tablets debossed with "RD" and "72" on one side and plain on the other side.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low.

To date, Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Morphine Sulfate Extended-Release Tablets are used to manage severe pain.

RECOMMENDATIONS:

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Patients that have these products should stop using them and contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178

Read Recall

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