Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

Drugs

March 9, 2021

Audience: Consumer, Patient, Health Professional, Pharmacy

March 9, 2021 — Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain Spironolactone 50 mg tablets.

A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to Hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors would be at increased risk. As of 3/9/2021 Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema and is repackaged in 30, 60 and 90-count bottles.

Lots included in recall:

Product Description NDC Lot # (Expiration Date)
Spironolactone 25 mg Tablets 63629106401 148969 (7/31/2022)
63629106402 148791 (7/31/2022)
63629106403 148991 (7/31/2022)
Spironolactone 50 mg Tablets 63629106701 148992 (5/31/2022)

The product can be identified by the following details on the label: Medication name as listed above with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo. Photos of the labels are provided in the photo section below.

Bryant Ranch Prepack is notifying its distributors and customers by mail and is arranging for return of all recalled products. Distributors that have existing inventory of any of the lots listed in this recalled should contact Bryant Ranch Prepack immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Mon.-Fri. 6:30am-6pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Source: FDA

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