Bryant Ranch Prepack, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12 (2 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0540-2024Class IIICephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexiMay 10, 2024
D-0538-2024Class IIICephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexMay 10, 2024
D-0539-2024Class IIICephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephaMay 10, 2024
D-0537-2024Class IIICephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephMay 10, 2024
D-0536-2024Class IIICephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant RanchMay 10, 2024
D-0556-2023Class IIILidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), April 20, 2023
D-1188-2022Class IMorphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: June 17, 2022
D-1187-2022Class IMorphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: June 17, 2022
D-1029-2018Class IIValsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, BJuly 27, 2018
D-1027-2018Class IIValsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-cJuly 27, 2018
D-1028-2018Class IIValsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2),July 27, 2018
D-0837-2016Class IIIVenlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), bMarch 25, 2016