APAP 325 mg 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 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
- Recall number
- D-0531-2022
- 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
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
Get recall alerts
Free email alert whenever ULTRAtab Laboratories, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: ULTRAtab Laboratories, Inc.