DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
Reported: February 9, 2022 Initiated: January 24, 2022 #D-0490-2022
Product Description
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- 2,685,700 packets
- Distribution
- Nationwide within the United States
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03. Recalled by Ultra Seal Corporation. Units affected: 2,685,700 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-0490-2022.
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