FDAFDA · Food and drugs·Recall number D-0537-2022
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Published February 16, 2022 · Recall initiated: January 26, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Distributor
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Lot
- Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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