CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
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 of a children's medication due to manufacturing process control deviations. The Class II classification indicates potential for adverse health consequences. However, the source does not identify a specific hazard and reports no illnesses or injuries, which limits the score to High per the rubric guidance.
Plain-English summary
CORRECTDOSE Children's Allergy Relief, containing Diphenhydramine HCl 12.5 mg per 5 mL, is subject to a Class II recall. The product was manufactured by Plastikon Healthcare LLC and distributed nationwide by Correct Dose Inc. of Braintree, Massachusetts, under NDC 62320-302-05.
The FDA determined that the products were manufactured under conditions in which manufacturing processes were not adequately controlled, constituting a CGMP (Current Good Manufacturing Practice) deviation.
The recalled product is distributed in 2.04 fl. oz. (60 mL) packages containing twelve 5 mL individual ampoules. The affected lot is Lot #21011A with an expiration date of January 2023, representing approximately 7,200 ampoules distributed nationwide in the United States.
Consumers should not use this recalled product. For return or disposal instructions, consumers should contact Correct Dose Inc., the distributing firm.
The recalled product
- Product
- CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
- Manufacturer
- Plastikon Healthcare LLC
- Hazard
- Affected units
- 7,200
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 # 21011A
- EXP Jan. 2023
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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