Home / Recalls / Precision Dose Inc. / D-1004-2020

D-1004-2020 Class II Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

Recall Details

Product Type
Drugs
Report Date
March 18, 2020
Initiation Date
November 13, 2019
Termination Date
September 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

Other recalls by Precision Dose Inc.

  • D-0095-2022 Class II — Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (N (November 1, 2021)
  • D-0094-2022 Class II — Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Indivi (November 1, 2021)
  • D-0228-2021 Class II — Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dos (January 1, 2021)
  • D-0057-2018 Class III — Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-3 (September 25, 2017)
  • D-1037-2017 Class II — Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, P (July 5, 2017)
  • D-250-2013 Class II — Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6809 (March 21, 2013)