Home / Recalls / Plastikon Healthcare LLC / D-1493-2022

D-1493-2022 Class II Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-1493-2022 was initiated by Plastikon Healthcare LLC on Jun 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. The recall status is terminated (terminated Jun 25, 2025). Affected quantity: 1,464 ampoules.

Recall details

Product Type: Drugs
Report Date: Sep 14, 2022
Initiation Date: Jun 7, 2022
Termination Date: Jun 25, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,464 ampoules

Product description

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 pattern

Distributed Nationwide in the USA

Code information

Lot # 20096A, EXP Oct. 2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1493-2022
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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