D-1004-2020 Class II Terminated
FDA drug recall D-1004-2020 was initiated by Precision Dose Inc. on Nov 13, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. The recall status is terminated (terminated Sep 17, 2022). Affected quantity: 224,940 unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 18, 2020
- Initiation Date
- Nov 13, 2019
- Termination Date
- Sep 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 224,940 unit dose cups
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
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Distribution Pattern
Nationwide USA
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1004-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026