Class II · Moderate risk
Creon (pancrelipase)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
PANCREAZE (pancrelipase)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,
Affected NDC
62541-0401-10
Compare with the code on your package — it is the most precise check available.
Drug: Pancrelipase
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pancreaze PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE NDC 62541-0401 |
PANCRELIPASE LIPASE 2600 [USP'U]/1; PANCRELIPASE AMYLASE 15200 [USP'U]/1; PANCRELIPASE PROTEASE 8800 [USP'U]/1 | Capsule, Delayed Release Oral |
Vivus LLC | Rx |
- Recalling firm
- Vivus, Inc.
- NDC code
- 62541-401-10
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0896-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Pancrelipase recalls
See all
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Class II · Moderate risk
Pancrelipase Dr
Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD
Class II · Moderate risk
Pancrelipase Dr
Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013.
Other stability / shelf life recalls from 2023
All stability / shelf life recalls
Class II · Moderate risk
Selenium Sulfide 2.25% Shampoo
CGMP Deviations: Stability data does not support expiry date.
Class II · Moderate risk
BD ChloraPrep Clear
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Class II · Moderate risk
Tizanidine Hydrochloride Tablet 4mg
Failed Stability Specifications
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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