FDA Drug recall D-0402-2021
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed b…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed b… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0402-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0032-1203-70 |
|---|---|
| ndc | 0032-1203-64 |
| ndc | 0032-1206-07 |
| ndc | 0032-1206-01 |
| ndc | 0032-1206-56 |
| ndc | 0032-1212-07 |
| ndc | 0032-1212-01 |
| ndc | 0032-1212-46 |
| ndc | 0032-1212-13 |
| ndc | 0032-1224-07 |
| ndc | 0032-1224-01 |
| ndc | 0032-1224-46 |
| ndc | 0032-3016-28 |
| ndc | 0032-3016-13 |
| ndc | 0032-3016-50 |
| ndc | 0032-3016-12 |
| ndc | 0032-0045-70 |
| ndc | 0032-0045-30 |
| ndc | 0032-0046-30 |
| ndc | 0032-0046-70 |
| ndc | 0032-0047-30 |
| ndc | 0032-0047-70 |
| ndc | 0032-2636-70 |
| ndc | 0032-2636-01 |
| ndc | 0032-2636-30 |
| ndc | 0032-2637-70 |
| ndc | 0032-2637-01 |
| ndc | 0032-2637-30 |
| code_info | 1139494 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0402-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.