Bella Pharmaceuticals Sterile Drug Recall [US]


US FlagUS/Silver Spring: Bella Pharmaceuticals Sterile Drug Recall [US]Bella Pharmaceuticals, Inc. recalls all batch/lots of its Sterile Drug Products due to suspected lack of Sterility Assurance, a serious and potential fatal situation, requiring immediate medical intervention. FDA: http://ht.ly/eZug30eLbOo

Direct link: https://www.fda.gov/Safety/Recalls/ucm572373.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug products are subject to this recall:

  • Avastin (Bevacizumab), packaged in BD 30g ½ and 31g 5/16 syringes; number of units distributed: 30 units; batch/lot: 3141201; expiration date: 9/13/17
  • Avastin (Bevacizumab), packaged in BD 30g ½ and 31g 5/16 syringes; number of units distributed: 310 units; batch/lot: 3146966; expiration date: 9/20/17
  • Avastin (Bevacizumab), packaged in BD 30g ½ and 31g 5/16 syringes; number of units distributed: 784 units; batch/lot: 3160608; expiration date: 10/5/17
  • Avastin (Bevacizumab), packaged in BD 30g ½ and 31g 5/16 syringes; number of units distributed: 646 units; batch/lot: 3146966; expiration date: 11/1/17
  • B-Complex, packaged in 30 ml vials; number of units distributed: 45 units; batch/lot: BPBC3080517; expiration date: 2/5/18
  • Calcium chloride 10%, packaged in 10 ml vials; number of units distributed: 5 units; batch/lot: 071217CC; expiration date: 10/12/18
  • Fluorescein Sodium, packaged in 5 ml vials; number of units distributed: 644 units; batch/lot: BPFS41717; expiration date: 4/1/18
  • GAC, packaged in 30 ml vials; number of units distributed: 3 units; batch/lot: 071217GAC; expiration date: 1/12/18
  • Glutathione 200mg/ml, packaged in 30 ml vials; number of units distributed: 82 units; batch/lot: 070617GL; expiration date: 1/6/18
  • L-Glutamine 100mg, packaged in 30 ml vials; number of units distributed: 5 number of units ; batch/lot: BPLG08517; expiration date: 2/5/18
  • Lidocaine Gel 3.5%, packaged in 15 ml droppers; number of units distributed: 6 units; batch/lot: BPLG3508717; expiration date: 11/7/17
  • Magnesium Chloride 200 mg, packaged in 30 ml vials; number of units distributed: 5 units; batch/lot: BPMC08517; expiration date: 2/5/18
  • Mannitol 20%, packaged in 10 ml vials; number of units distributed: 10 units; batch/lot: 070717ML; expiration date: 1/718
  • Methylcobalamin 10 mg/ml, packaged in 30 ml vials; number of units distributed: 7 units; batch/lot: BPMC30072917; expiration date: 1/29/18
  • Methylcobalamin 1mg/ml, packaged in 30 ml vials; number of units distributed: 30 units; batch/lot: 070717MC; expiration date: 1/7/18
  • MIC 25/50/50, packaged in 30 ml vials; number of units distributed: 5 units; batch/lot: BPMIC30072917; expiration date: 1/29/18
  • Phenylephrine2.5%/Tropicamide 1%, packaged in 15 ml droppers; number of units distributed: 6 units; batch/lot: BPPTC08717; expiration date: 11/17/17
  • Sodium Bicarbonate 8.4%, packaged in 10 ml vials; number of units distributed: 20 units; batch/lot: BPSB8408717; expiration date: 11/7/17

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. Additional images of the recalled drugs can be found on the Web site above.

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, Bella Pharmaceuticals has recalled all lots of unexpired Sterile Drug Products due to lack of sterility assurance. The recalled products were distributed to health care facilities US nationwide.

The FDA reports the administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.

The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination.

If you believe you have purchased or have in your possession any of the recalled drugs, please do not administer them directly nor in a Central Line. Instead, return the drug to the store where you pharmacist or dispensary.

If you have any questions about this recall, please contact Bella Pharmaceuticals by 1-877-235-5279 from 9:00 AM to 5:00 PM Central Time.

==> To see other recalls and notifications caused by suspected contaminated or adulterated drugs, please search for “drug” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 9135-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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