FDA recall D-1493-2022

Product

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-07

Report date

2022-09-14

Termination date

2025-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1493-2022