CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations
CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing control deviations and no reported illnesses or injuries. This is a risk-of-harm situation for a children's medication where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
CORRECTDOSE Children's Pain Relief and Fever Reducer is a children's liquid medication containing acetaminophen 160 mg per 5 mL. It is packaged in 2.04 FL. OZ (60 mL) bottles containing twelve individual 5 mL doses. The recall affects Lot #20096A, expiring October 2022, identified by NDC 62320-311-05.
The product has been recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing processes were not adequately controlled during production.
The affected product was distributed nationwide in the United States by Correct Dose Inc, Braintree, Massachusetts. The recall involves 1,464 ampoules. Consumers should not use this product and should contact their healthcare provider with any questions or concerns about this recall.
The recalled product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Children's Fever Reducer
- Hazard
- Affected units
- 1,464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20096A
- EXP Oct. 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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