PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 14, 2022 Initiated: June 7, 2022 #D-1493-2022

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.

Details

Recalling Firm
Plastikon Healthcare LLC
Units Affected
1,464 ampoules
Distribution
Distributed Nationwide in the USA
Location
Lawrence, KS

Frequently Asked Questions

What product was recalled?
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. Recalled by Plastikon Healthcare LLC. Units affected: 1,464 ampoules.
Why was this product recalled?
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 14, 2022. Severity: Moderate. Recall number: D-1493-2022.