Bella Pharmaceuticals Recalls Lidocaine Ophthalmic Gel Due to Sterility Concerns
Bella Pharmaceuticals is recalling Lidocaine Ophthalmic Gel 3.5% because the product lacks 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 involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection and potential serious injury.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, prescription only. The recall is due to a lack of assurance of sterility.
The affected product is identified by Lot # BPLG3508717 with an expiration date of 11/7/17. A total of 6 bottles were involved in this recall. The product was distributed nationwide within the USA.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- 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 #: BPLG3508717
- 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.
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