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Bryant Ranch Prepack Inc. Voluntarily Recalls Morphine Sulfate 30 mg and 60 mg Extended Release Due to Label Mix Up

Bryant Ranch Prepack Inc. Voluntarily Recalls Morphine Sulfate 30 mg and 60 mg Extended Release Due to Label Mix Up

Ranch Prepack Inc. has issued a voluntary recall of 10 bottles of Morphine Sulfate 30 mg extended-release and 10 bottles of Morphine Sulfate 60 mg extended-release tablets at the consumer level.

According to the notice, some bottles of 30 mg tablets were incorrectly labelled as 60 mg tablets and vice versa. The dosage strength is printed in large font on the front panel of each bottle and the lot number is printed on the side panel, below the barcode.

This recall affects products with the following lot numbers:

  1. Morphine Sulfate 30 mg extended-release tablets
  • Lot number 179642
  • NDC 63629-1088-01
  • Expiry 11/30/2023
  1. Morphine Sulfate 60 mg extended-release tablets
  • Lot number 179643
  • NDC 63629-1089-01
  • Expiry 08/31/2023

Risk Statement

The extended-release feature of the 36-hour tablet is designed to provide a slow, steady release of medication over an extended period. Ingesting a 60 mg tablet instead of 30 mg may result in too much medicine being released into the body at one time. This overdose could cause serious health consequences, including death.

Patients who have a 60 mg prescription but receive a 30 mg dose may not receive the adequate pain relief and may experience withdrawal. Bryant Ranch Prepack Inc. has not received any reports of adverse events.

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Morphine sulfate extended-release tablets are used as pain medication for moderate to severe pain. You can recognise the 30 mg tablets by their round, purple color, and film coat with “RD” and “71” debossed on one side. The 60 mg tablets are round and have a light-orange color with “RD” and “72” debossed on one side and the other side plain.

Bryant Ranch Prepack is notifying its distributors and customers by email, phone, and letter and is arranging for the return of all recalled products. Patients who have these products are instructed to stop using them and contact their pharmacist or healthcare provider to return the affected product immediately.

Patients with questions regarding this recall can contact Bryant Ranch Prepack Monday-Friday 7:30 am-5:00 pm PDT by 877-885-0882 or at [email protected]. Consumers who experience problems as a result of taking this medication should contact a healthcare professional.

Any complaints regarding adverse reactions or quality issues can be reported to the FDA at www.fda.gov/medwatch, by phone at 1- 800-332-1088 or fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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