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Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), ...

FDA Recall #D-0814-2021 — Class II — September 3, 2021

Recall #D-0814-2021 Date: September 3, 2021 Classification: Class II Status: Completed

Product Description

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 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: 60432-608-16

Reason for Recall

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

Recalling Firm

Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

116,400 bottles

Distribution

Nationwide USA and China

Code Information

Lot #: UV1335; UV1352; and UV1373

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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