CutisPharma Recalls Omeprazole Kits Due to Labeling Error
CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error.
Plain-English summary
CutisPharma, Inc. is recalling 8,748 kits of FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit, 5 oz., Rx only. The product is identified by Lot # E1414 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 of the insert incorrectly states the strength as 3mg per mL, whereas the correct strength is 2mg per mL.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for this specific lot and expiration date and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
- Manufacturer
- CutisPharma, Inc.
- Category
- Drug — Compounding Kit
- Hazard
- Affected units
- 8,748
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 #: E1414
- 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.
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