Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1492-2022
Event ID90398
DistributionDistributed Nationwide in the USA
Quantity7,200 ampoules
Recall ReasonCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Drug ClassificationClass II
Drug Code Info20220914
Recall Initiation Date20220607
Report Date20220914
Classification Date20220906
Address3780 Greenway Cir
Lawrence, KS 66046-5440
United States
Recalling FirmPlastikon Healthcare LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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