Class II
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 Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
This recall has been terminated (originally issued March 18, 2020).
- Company
- Precision Dose Inc.
- Recall Initiated
- November 13, 2019
- Posted
- March 18, 2020
- Recall Number
- D-1004-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 224,940 unit dose cups
- Firm Location
- South Beloit, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Distribution
Nationwide USA
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
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