Home / Recalls / Morton Grove Pharmaceuticals, Inc. / D-0815-2021

D-0815-2021 Class II

Recalled by Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL

Recall Details

Product Type: Drugs
Report Date: September 29, 2021
Initiation Date: September 3, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,904 bottles

Product Description

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

Reason for Recall

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

Distribution Pattern

Nationwide USA and China

Code Information

Lot #: UV1198

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D-0816-2021 Class II — Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manu (September 3, 2021)
D-0174-2021 Class II — Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) (December 9, 2020)
D-0130-2020 Class II — Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz ( (September 23, 2019)
D-1042-2018 Class II — Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle (July 24, 2018)
D-1125-2017 Class II — Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per (August 10, 2017)
D-0571-2016 Class III — Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, (December 15, 2015)