Bella Pharmaceuticals Recalls G.A.C Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling G.A.C 25/100/250mg vials because the company cannot ensure the product is sterile.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling G.A.C 25/100/250mg, 30 mL Vials, which are prescription-only medications. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected product includes 3 vials per unit. The specific lot number is 071217GAC, with a date of 1/12/18. The product was distributed nationwide within the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or Bella Pharmaceuticals for further instructions.
The recalled product
- Product
- G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 3
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 #: 071217GAC
- 1/12/18
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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