ULTRAtab Laboratories, Inc.: Drug Recall

Recall #D-0549-2022 · 01/26/2022

Class II: Risk

Recall Details

Recall Number
D-0549-2022
Classification
Class II
Product Type
Drug
Recalling Firm
ULTRAtab Laboratories, Inc.
Status
Terminated
Date Initiated
01/26/2022
Location
Highland, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
452,038 tablets

Reason for Recall

CGMP Deviations

Product Description

Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00

Distribution Pattern

Bulk product was distributed to 3 distributors who may have distributed finished product.

Other Recalls by ULTRAtab Laboratories, Inc.

View all recalls by ULTRAtab Laboratories, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.