FDA Drug recall D-1492-2022
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, Dis…
- FDA Drug
- Class II
- terminated
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of 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, Dis… by Plastikon Healthcare, citing CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1492-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-07 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Plastikon Healthcare |
| Distribution | US |
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
Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Identifiers
| upc | 860003671443 |
|---|---|
| code_info | Lot # 21011A, EXP Jan. 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1492-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.