Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Reported: January 17, 2018 Initiated: December 4, 2017 #D-0154-2018
Product Description
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Reason for Recall
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Details
- Recalling Firm
- ALLERGAN
- Units Affected
- 12,699 bottles
- Distribution
- U.S.A. nationwide
- Location
- Madison, NJ
Frequently Asked Questions
What product was recalled? ▼
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10. Recalled by ALLERGAN. Units affected: 12,699 bottles.
Why was this product recalled? ▼
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0154-2018.
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