Drug recall D-0419-2021

Class II Terminated reported Jun 2, 2021

Product

Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

2399070

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
31 tubes
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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