Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Affected NDC
65628-0070-05
Compare with the code on your package — it is the most precise check available.
Drug: Omeprazole Category: Heartburn & Stomach Medication
- Recalling firm
- CutisPharma, Inc.
- NDC code
- 65628-070-05
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0138-2017 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Omeprazole recalls
See all
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Good Sense Omeprazole Tablet 14ct Sku 900055 Prilosec OTC…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Other recalls by CutisPharma, Inc.
All 2016 recalls
Class III · Low risk
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
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