The Recall Desk
CriticalFDA (Drugs)·D-1188-2022·Announced 2022-07-20

Morphine Sulfate Extended-Release Tablets Recalled for Strength Label Mix-up

Bryant Ranch Prepack has recalled Morphine Sulfate extended-release tablets due to a label mix-up where bottles may contain the wrong strength. Contact your pharmacy to verify your correct dose.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is classified as an FDA Class I recall, which the severity rubric identifies as meeting the Critical threshold. FDA Class I represents the highest-level FDA classification for medication recalls, indicating a serious and potentially life-threatening hazard.

Plain-English summary

Bryant Ranch Prepack, Inc. is recalling Morphine Sulfate extended-release tablets due to a serious label mix-up. Affected bottles labeled as 60 mg may contain 30 mg tablets, and bottles labeled as 30 mg may contain 60 mg tablets. The affected product is Morphine Sulfate extended-release tablets, USP, in 100-count bottles, with Lot #179643 and an expiration date of 08/31/2023. The product was manufactured by Ohm Laboratories Inc. and relabeled by Bryant Ranch Prepack, Inc.

The label mix-up means patients may be taking a different strength of medication than prescribed. This could result in inadequate pain management (if receiving the lower dose) or potential overdose risks (if receiving the higher dose). The affected medication was distributed to one wholesaler in Alabama for further distribution within the United States.

Patients who have received this medication should immediately contact their pharmacy to verify that their bottles contain the correct strength as prescribed by their healthcare provider. If you have received Morphine Sulfate extended-release tablets with Lot #179643, do not take the medication until the strength has been verified with your pharmacy.

The recalled product

Product
Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
Manufacturer
Bryant Ranch Prepack, Inc.
Category
Drug
Hazard
  • mis-labeling
  • wrong-strength

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 #: 179643
  • Exp. Date 08/31/2023.

Distribution

Distributed in 1 state:

  • AL

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