Reported Mar 18, 2020 · Terminated
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…
Precision Dose Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Precision Dose Inc. · 722 Progressive Ln · South Beloit, IL · 61080-2616
Is this the product you have?
- Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case
- NDC
68094-204-6210 mL x 100 Unit Dose Cups per case
- NDC68094-204-61
- Unit Dose Cup NDC68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61 2 Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62 3 Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62 4 Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62 5 Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62 - Amount recalled
- 224,940 unit dose cups
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
This product could cause temporary or reversible health problems — stop using it.
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