Home / Recalls / Bryant Ranch Prepack Inc. / D-1029-2018

D-1029-2018 Class II Terminated

Recalled by Bryant Ranch Prepack Inc. — Burbank, CA

Recall Details

Product Type
Drugs
Report Date
August 8, 2018
Initiation Date
July 27, 2018
Termination Date
April 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90 tablets

Product Description

Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Product was distributed in HI, IN, and FL.

Code Information

Lot # 120879; Exp 10/19

Other recalls by Bryant Ranch Prepack Inc.

  • D-0540-2024 Class III — Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Eac (May 10, 2024)
  • D-0538-2024 Class III — Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Ea (May 10, 2024)
  • D-0539-2024 Class III — Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), (May 10, 2024)
  • D-0537-2024 Class III — Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), (May 10, 2024)
  • D-0536-2024 Class III — Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabe (May 10, 2024)
  • D-0556-2023 Class III — Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per car (April 20, 2023)
  • D-1188-2022 Class I — Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx onl (June 17, 2022)
  • D-1187-2022 Class I — Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx onl (June 17, 2022)
  • D-1027-2018 Class II — Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( (July 27, 2018)
  • D-1028-2018 Class II — Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (July 27, 2018)