Dologen 325 Caplet 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 Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc…
- Recall number
- D-0527-2022
- 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
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
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