FDA recall D-1492-2022

Plastikon Healthcare LLC · Class II · drug

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 for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-06-07
Report date: 2022-09-14
Termination date: 2025-06-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lawrence, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1492-2022