Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office

NDC code

0904-6461-61

Origin

VA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1057-2022

Other Promethazine recalls

See all

Class II · Moderate risk Ongoing Apr 26, 2023

Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0838-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0837-2023

Class II · Moderate risk Terminated Dec 6, 2021

Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1341-01 D-0446-2022

Class II · Moderate risk Completed Sep 3, 2021

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473…

Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Morton Grove Pharmaceuticals, Inc. D-0815-2021

Class II · Moderate risk Completed Sep 3, 2021

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For…

Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Morton Grove Pharmaceuticals, Inc. D-0814-2021