SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
Reported: February 9, 2022 Initiated: January 24, 2022 #D-0489-2022
Product Description
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- 122,400 packets
- Distribution
- Nationwide within the United States
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00. Recalled by Ultra Seal Corporation. Units affected: 122,400 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-0489-2022.
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