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
Reported: February 9, 2022 Initiated: January 24, 2022 #D-0474-2022
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
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- a) 9,060 bottles, b) 44,700 packets
- Distribution
- Nationwide within the United States
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ultra Seal Corporation. Units affected: a) 9,060 bottles, b) 44,700 packets.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 9, 2022. Severity: Moderate. Recall number: D-0474-2022.
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