Bella Pharmaceuticals Recalls Phenylephrine/Tropicamide Ophthalmic Solution for Sterility Concerns
Bella Pharmaceuticals is recalling 6 bottles of Phenylephrine 2.5%/Tropicamide 1% Ophthalmic Solution due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 6 bottles of Phenylephrine 2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottles, prescription only. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot # BPPTC08717 with an expiration date of 11/7/17. The product was distributed nationwide within the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 6
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 #: BPPTC08717
- Exp. 11/7/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Bella Pharmaceuticals, 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 16 products in this recall →Related recalls
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