Bella Pharmaceuticals Recalls Bevacizumab Syringes Due to Sterility Concerns
Bella Pharmaceuticals is recalling 2,334 Bevacizumab prefilled syringes nationwide 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 a medical product, which carries a risk of serious injury or infection.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 2,334 prefilled syringes of Bevacizumab (30g and 31 gram, 1.25mg/0.05mL) because of a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide within the United States.
The recall involves specific lots with expiration dates ranging from September 13, 2017, to November 1, 2017. The identified lot numbers are 3141201, 3146966, and 3160608.
Healthcare providers and patients should stop using the affected syringes and contact Bella Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Biologic / Injectable
- Affected units
- 2,334
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 (7)
- Lot #: 3141201
- Exp. 9/13/17
- 3146966
- Exp . 9/20/17
- 3160608
- Exp. 10/5/17
- Exp. 11/1/17
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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