Reported Feb 16, 2022 · Terminated
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab…
ULTRAtab Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ULTRAtab Laboratories, Inc. · 50 Toc Dr · Highland, NY · 12528-1506
Is this the product you have?
- 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
- Lot codes and dates
- Product CodesC134LC
- Bulk Lots
18K05518M08119A09719B02419C05419E09219G09419J042
- Amount recalled
- 14,566,510 tablets
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Why it was recalled
CGMP Deviations
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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