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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bella Pharmaceuticals, Inc.: Various Sterile Injectable Medications Recalled for Lack of Sterility

Agency Publication Date: September 12, 2017
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Summary

Bella Pharmaceuticals is recalling 3,407 units of various sterile injectable medications and ophthalmic (eye) products, including Glutathione, Methylcobalamin, and Bevacizumab, due to concerns that they may not be sterile. The recall was initiated after a lack of assurance of sterility was identified, which could lead to serious infections in patients receiving these injections. These products were distributed nationwide in the United States between July and August 2017. Consumers should immediately stop using any remaining products from the affected lots and consult with their healthcare provider.

Risk

If an injectable or eye medication is not sterile, it can introduce bacteria or other microorganisms directly into the body or the eye, potentially causing life-threatening infections, permanent vision loss, or other severe health complications.

What You Should Do

  1. Check your medication vials, bottles, or prefilled syringes for the following affected lot numbers: 070617GL, 070717MC, 070717ML, 071217GAC, 071217CC, BPBC3080517, BPMC30072917, BPMC08517, BPLG08517, BPMIC30072917, BPLG3508717, BPPTC08717, BPSB8408717, BPFS41717, 3141201, 3146966, 3160608, or 08152017.
  2. Identify the expiration dates on your packaging to see if they match the recalled range, which includes dates from September 13, 2017, through October 12, 2018.
  3. Stop using any medication identified in this recall immediately to prevent the risk of infection.
  4. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects you may have experienced.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Bella Pharmaceuticals at 1-877-235-5211 for further instructions on how to handle the recalled items.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund upon return of unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: PF-Glutathione 200mg/ml (30 mL vial)
Model:
D-1146-2017
Lot Numbers:
070617GL (Exp. 1/6/18)
Date Ranges: Expiration Date: 1/6/18
Product: Methylcobalamin 10mg (1mg/ml) (30 mL vial)
Model:
D-1147-2017
Lot Numbers:
070717MC (Exp. 1/7/18)
Date Ranges: Expiration Date: 1/7/18
Product: Mannitol 20% (10 mL vial)
Model:
D-1148-2017
Lot Numbers:
070717ML (Exp. 1/7/18)
Date Ranges: Expiration Date: 1/7/18
Product: G.A.C 25/100/250mg (30 mL vial)
Model:
D-1149-2017
Lot Numbers:
071217GAC (Exp. 1/12/18)
Date Ranges: Expiration Date: 1/12/18
Product: Calcium chloride 10% (10 mL vial)
Model:
D-1150-2017
Lot Numbers:
071217CC (Exp. 10/12/18)
Date Ranges: Expiration Date: 10/12/18
Product: B-Complex (30 mL vial)
Model:
D-1151-2017
Lot Numbers:
BPBC3080517 (Exp. 2/5/18)
Date Ranges: Expiration Date: 2/5/18
Product: Methylcobalamin 10mg (10mg/ml) (30 mL vial)
Model:
D-1152-2017
Lot Numbers:
BPMC30072917 (Exp. 1/29/18)
Date Ranges: Expiration Date: 1/29/18
Product: Magnesium Chloride 200mg (30 mL vial)
Model:
D-1153-2017
Lot Numbers:
BPMC08517 (Exp. 2/5/18)
Date Ranges: Expiration Date: 2/5/18
Product: L-Glutamine 100mg (30 mL vial)
Model:
D-1154-2017
Lot Numbers:
BPLG08517 (Exp. 2/5/18)
Date Ranges: Expiration Date: 2/5/18
Product: MIC 25/50/50 (30 mL vial)
Model:
D-1155-2017
Lot Numbers:
BPMIC30072917 (Exp. 1/29/18)
Date Ranges: Expiration Date: 1/29/18
Product: Lidocaine Ophthalmic Gel 3.5% (15 mL bottle)
Model:
D-1156-2017
Lot Numbers:
BPLG3508717 (Exp. 11/7/17)
Date Ranges: Expiration Date: 11/7/17
Product: Phenylephrine 2.5% / Tropicamide 1% Ophthalmic Solution (15 mL bottle)
Model:
D-1157-2017
Lot Numbers:
BPPTC08717 (Exp. 11/7/17)
Date Ranges: Expiration Date: 11/7/17
Product: Sodium Bicarbonate 8.4% (10 mL vial)
Model:
D-1158-2017
Lot Numbers:
BPSB8408717 (Exp. 11/7/17)
Date Ranges: Expiration Date: 11/7/17
Product: Fluorescein Sodium (5 mL vial)
Model:
D-1159-2017
Lot Numbers:
BPFS41717 (Exp. 4/1/18)
Date Ranges: Expiration Date: 4/1/18
Product: Bevacizumab Prefilled Syringes (30g and 31g, 1.25mg/0.05mL)
Model:
D-1160-2017
Lot Numbers:
3141201 (Exp. 9/13/17)
3146966 (Exp. 9/20/17)
3160608 (Exp. 10/5/17)
3146966 (Exp. 11/1/17)
Date Ranges: Expiration Dates: 9/13/17, 9/20/17, 10/5/17, 11/1/17
Product: BevaDex (bevacizumab) Prefilled Syringes (32g, 1.25mg/1mg, 0.06mL)
Model:
D-1161-2017
Lot Numbers:
08152017 (Exp. 11/15/17)
Date Ranges: Expiration Date: 11/15/17

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77959
Status: Resolved
Manufacturer: Bella Pharmaceuticals, Inc.
Sold By: Specialty pharmacies; Healthcare facilities
Manufactured In: United States
Units Affected: 16 products (82 vials; 30 vials; 10 vials; 3 vials; 5 vials; 45 vials; 7 vials; 5 vials; 5 vials; 5 vials; 6 bottles; 6 bottles; 20 vials; 644 vials; 2,334 syringes; 200 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.