FDA Recalls Diclo 3% Cream Due to Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream because inspection observations indicate a lack of assurance of 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls involving significant risks to sterility or quality assurance, which can lead to serious health consequences, are categorized as Severe (Score 4).
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream. The recall was initiated due to recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. The FDA has classified this recall as Class II.
The source text indicates that the lack of assurance of sterility and stability data does not support the product's expiry. The distribution pattern is listed as NC (North Carolina), and the recall covers all lots of the product. The product was manufactured by Health Innovations Pharmacy, Inc., located at 295 Pinehurst Ave, Southern Pines, NC 28387.
Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical Cream
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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