Bella Pharmaceuticals Recalls BevaDex Syringes Due to Sterility Concerns
Bella Pharmaceuticals is recalling 200 prefilled BevaDex syringes nationwide because the company cannot guarantee the product's 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 a medical product, which poses a significant risk of serious injury or infection.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 200 prefilled syringes of BevaDex (bevacizumab) 0.06mL. The product is a prescription-only medication manufactured by Bella Pharmaceuticals, Inc. in Chicago, Illinois. The specific lot number is 08152017, with an expiration date of 11/15/17.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the syringes are free from microbial contamination. The affected products were distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected BevaDex syringes immediately. They should contact their healthcare provider for guidance on alternative treatments and contact Bella Pharmaceuticals at (877) BELLA for further instructions on returning or disposing of the product.
The recalled product
- Product
- BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 200
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 #: 08152017
- Exp. 11/15/17
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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