RecallRadar

FDA Drug recall D-1493-2022

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individu…

On 2022-09-14 the FDA classified a Class II recall of CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individu… by Plastikon Healthcare, citing CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1493-2022
ClassificationClass II
Statusterminated
Initiated2022-06-07
Published2022-09-14
Last updated2026-09-13 11:52 UTC
CompanyPlastikon Healthcare
DistributionUS

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

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

Identifiers

upc860003671450
code_infoLot # 20096A, EXP Oct. 2022

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-1493-2022%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.