Burbank, CA, United States
Bryant Ranch Prepack, Inc. recalls
4 recalls recorded since 2018, most recently on 10 May 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)1
Ongoing Class III Drugs
- Recall started
- 10 May 2024
- Reason
- Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0537-2024, D-0539-2024, D-0538-2024, D-0540-2024, D-0536-2024
- Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laborat
- Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch P
- Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prep
- Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepa
- Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Ongoing Class III Drugs
- Recall started
- 20 April 2023
- Reason
- Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0556-2023
- Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories
Terminated Class I Drugs
- Recall started
- 17 June 2022
- Terminated
- 2 April 2024
- Reason
- Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
- Distribution
- Distributed to one wholesaler in AL for further distribution in the US.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1188-2022, D-1187-2022
- Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
- Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC
Terminated Class II Drugs
- Recall started
- 27 July 2018
- Terminated
- 22 April 2021
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Product was distributed in HI, IN, and FL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1027-2018, D-1029-2018, D-1028-2018
- Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.