Correctdose Children's Allergy Relief recall: CGMP Deviations
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
Why was Correctdose Children's Allergy Relief 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 # 21011A, EXP Jan. 2023
- 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
- Recalling firm
- Plastikon Healthcare LLC
- Quantity
- 7,200 ampoules
- Distribution
- Distributed Nationwide in the USA
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)