Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured F
Summary
The FDA issued a Class II for Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), by Morton Grove Pharmaceuticals, Inc.. Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms..
Details
Source
Drug Recall
External ID
D-0814-2021
Action Date
2021-09-29
Status
Completed
Category
drug
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
Lot/Code Info: Lot #: UV1335; UV1352; and UV1373
Quantity Affected: 116,400 bottles
Reason for Recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Distribution
Nationwide USA and China
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-03
Company
Morton Grove, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Morton Grove Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Morton Grove Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Morton Grove Pharmaceuticals, Inc. have FDA actions?
Morton Grove Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0814-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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