RecallRadar

FDA Drug recall D-0548-2022

APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00

On 2022-02-16 the FDA classified a Class II recall of APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00 by Ultratab Laboratories, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0548-2022
ClassificationClass II
Statusterminated
Initiated2022-01-26
Published2022-02-16
Last updated2026-09-13 11:52 UTC
CompanyUltratab Laboratories
Distributionn/a

Product

APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00

Reason

CGMP Deviations

Identifiers

code_infoProduct Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0548-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.