Health Innovations Pharmacy Recalls Ibuprofen 10% Cream Due to Sterility Concerns
Health Innovations Pharmacy is recalling Ibuprofen 10% cream in North Carolina due to quality control issues affecting sterility and stability data.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility risks that could lead to hospitalization or significant injury.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling all lots of Ibuprofen 10% cream. The product was distributed in North Carolina.
The recall was initiated because recent inspection observations identified issues with certain quality control procedures. These issues present a risk to the sterility and quality assurance of the product, as stability data does not support the expiry date.
Consumers who have purchased this product should stop using it and contact Health Innovations Pharmacy for further instructions.
The recalled product
- Product
- Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical Analgesic
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, 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.
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