Drug recall D-0402-2021
Product
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
1139494
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 1669 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Creon – drug information
- NDC 0032-3016 Creon · Pancrelipase Lipase 36000 [USP'U]/1; Pancrelipase Amylase… · AbbVie Inc.
- NDC 0032-1203 Creon · Pancrelipase Amylase 15000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.
- NDC 0032-0047 Creon · Pancrelipase Amylase 60000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.
- NDC 0032-2637 Creon · Pancrelipase Lipase 36000 [USP'U]/1; Pancrelipase Amylase… · AbbVie Inc.
- NDC 0032-1212 Creon · Pancrelipase Amylase 60000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.
- NDC 0032-2636 Creon · Pancrelipase Lipase 24000 [USP'U]/1; Pancrelipase Protease… · AbbVie Inc.
- NDC 0032-0046 Creon · Pancrelipase Amylase 30000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.
- NDC 0032-1206 Creon · Pancrelipase Amylase 30000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.
- NDC 0032-1224 Creon · Pancrelipase Lipase 24000 [USP'U]/1; Pancrelipase Protease… · AbbVie Inc.
- NDC 0032-0045 Creon · Pancrelipase Amylase 15000 [USP'U]/1; Pancrelipase Lipase… · AbbVie Inc.