Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1004-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 13, 2019
- FDA report date
- Mar 18, 2020
- Quantity
- 224,940 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-1004-2020, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85039
- Address
- 722 Progressive Ln
- Code information
- 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
- Postal code
- 61080-2616
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-1004-2020
- Classification
- Class II
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 224,940 unit dose cups
- Termination date
- Sep 17, 2022
- Reason for recall
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2020