Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Reported: February 16, 2022 Initiated: January 26, 2022 #D-0528-2022
Product Description
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Units Affected
- 14,566,510 tablets
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Location
- Highland, NY
Frequently Asked Questions
What product was recalled? ▼
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00. Recalled by ULTRAtab Laboratories, Inc.. Units affected: 14,566,510 tablets.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 16, 2022. Severity: Moderate. Recall number: D-0528-2022.
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