FDAAugust 7, 2017drug
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
What to do
FDA enforcement status: Terminated
Brands named
international laboratoriesinternational
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDAVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bottle, 47 SERVING PER BOTTLE, 24 bottles- 8 FL Oz (237mL) Amber PET modern round bottles per package, Store at room. Mnfg by: Llorens Pharmaceutical Miami, FL2026-05-07
- FDAAmlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.2026-05-05
- FDAAscend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.2026-04-27
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