Drug & medication recalls Moderate risk

HPC Tablet Bulk Container recalled over manufacturing violations

Recall date
January 26, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
ULTRAtab Laboratories, Inc. recalls HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Labor…
Recall number
D-0538-2022
FDA classification
Class II
Brand / firm
ULTRAtab Laboratories, Inc.
Sold / distributed
Bulk product was distributed to 3 distributors who may have distributed finished product.

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00

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