FDAClass IISeptember 14, 2022

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer recall: CGMP Deviations

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

Why was CORRECTDOSE Children's PAIN RELIEF & Fever Reducer recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 20096A, EXP Oct. 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
Recalling firm
Plastikon Healthcare LLC
Quantity
1,464 ampoules
Distribution
Distributed Nationwide in the USA
Recall date
September 14, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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