D-0495-2022 Class II Terminated
FDA drug recall D-0495-2022 was initiated by Ultra Seal Corporation on Jan 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 447,050 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 24, 2022
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 447,050 packets
Product Description
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AK9478, Exp. Date 02/2022; AK9799, Exp. Date 09/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0495-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026