FDANovember 13, 2019drug
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
What to do
FDA enforcement status: Terminated
Brands named
precision doseprecision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAJewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.2025-05-23
- FDAJewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.2025-05-22
- FDA1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted case, 32 per case / 2.5 gal yield item number 159016044 2. Sqwincher Electrolyte Beverage Mix, grape powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025...2024-09-09
- FDASqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 1590164042024-09-09
- CPSCCrye Precision Recalls LRB™ Leg Loops Due to Fall Hazard (Recall Alert)2022-07-21
- CPSCTech Lighting Recalls Coda Pendant Light Fixtures Due to Impact Injury Hazard (Recall Alert)2022-06-23
- FDAThick-It Original Food & Beverage Thickener 6/36 oz. jars per case2022-06-09
- FDAAcetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.2021-11-01
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