COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
Reported: February 9, 2022 Initiated: January 24, 2022 #D-0487-2022
Product Description
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- 226,400 packets
- Distribution
- Nationwide within the United States
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556. Recalled by Ultra Seal Corporation. Units affected: 226,400 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-0487-2022.
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