Reported Feb 16, 2022 · Terminated
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 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?
- 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published C106L— C106LABulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065 — Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027 - Amount recalled
- 33,758,436 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.
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