D-0474-2022 Class II Terminated
FDA drug recall D-0474-2022 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: a) 9,060 bottles, b) 44,700 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
- a) 9,060 bottles, b) 44,700 packets
Product Description
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0474-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026