CutisPharma Recalls Omeprazole Compounding Kits Due to Labeling Error
CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error with no reported injuries.
Plain-English summary
CutisPharma, Inc. is recalling 5,904 kits of FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit, 3 OZ, Rx only. The product is identified by NDC# 65628-070-03, Lot # E1396, and an expiration date of 08/2018. The kits were distributed nationwide.
The recall was initiated due to a labeling error in the package insert. The Description section incorrectly states the strength as 3mg per mL, whereas the correct strength is 2mg per mL. This discrepancy is limited to the written documentation provided with the product.
Healthcare providers and patients should verify the correct strength of the medication against the physical product or official prescribing information. No illnesses or injuries have been reported in connection with this labeling error.
The recalled product
- Product
- FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
- Manufacturer
- CutisPharma, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,904
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: E1396
- Exp. 08/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by CutisPharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CutisPharma, Inc.
See all →- LowCutisPharma Recalls Omeprazole Kits Due to Labeling Error
FDA (Drugs) · 2016-11-23
Same hazard · mis labeling
See all →- High
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