Recalls / Class II
Class IID-1004-2020
Product
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
- Affected lot / code info
- Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62; Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Recalling firm
- Firm
- Precision Dose Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 224,940 unit dose cups
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-11-13
- FDA classified
- 2020-03-12
- Posted by FDA
- 2020-03-18
- Terminated
- 2022-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1004-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.