Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, I
Summary
The FDA issued a Class II for Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg by ULTRAtab Laboratories, Inc.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0525-2022
Action Date
2022-02-16
Status
Terminated
Category
drug
Product Description
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Lot/Code Info: Product Codes: C111L Bulk Lot: 18L028
Quantity Affected: 1,798,048 tablets
Reason for Recall
CGMP Deviations
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-26
Company
Highland, NY
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 104 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
ULTRAtab Laboratories, Inc. has 43 FDA actions in our database, including 43 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 (ULTRAtab Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ULTRAtab Laboratories, Inc. have FDA actions?
ULTRAtab Laboratories, Inc. has 43 FDA actions in our database, including 43 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0525-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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