Recall D-1492-2022
Description: 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
Recall D-1492-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1492-2022 |
| Event ID | 90398 |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 7,200 ampoules |
| Recall Reason | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. |
| Drug Classification | Class II |
| Drug Code Info | 20220914 |
| Recall Initiation Date | 20220607 |
| Report Date | 20220914 |
| Classification Date | 20220906 |
| Address | 3780 Greenway Cir Lawrence, KS 66046-5440 United States |
| Recalling Firm | Plastikon Healthcare LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |