Dologen recall: CGMP Deviations
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
Why was Dologen recalled?
cGMP deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
- Product
- 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
- Recalling firm
- Ultra Seal Corporation
- Quantity
- a) 9,060 bottles, b) 44,700 packets
- Distribution
- Nationwide within the United States
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)