The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-412-2014·Announced 2014-01-22

FDA Recalls Bevacizumab Due to Lack of Assurance of Sterility

Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for a drug product, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling 2,801 doses of repackaged Bevacizumab in 0.11 mL and 0.06 mL vials. The recall was initiated because the products were compounded in the same environment and under the same practices as another product found to be non-sterile, meaning the sterility of these specific doses cannot be assured.

The affected products are prescription-only and were manufactured and distributed between July 1, 2013, and October 19, 2013. Distribution was limited to hospitals, clinics, physicians, and patients in the Michigan area. Specific lot numbers are listed in the official recall notice.

Consumers and healthcare providers should stop using the recalled products and contact the pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer
Specialty Medicine Compounding Pharmacy
Category
Drug — Biologic
Hazard
Affected units
2,801

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 (20)

  • All unexpired lots
  • manufactured and distributed between 07/01/2013 and 10/19/2013
  • including Lot #s: for both sizes: 08072013@26
  • 08282013@52
  • 09112013@31
  • 09162013@33
  • 10072013@33
  • 07242013@47
  • 08082013@42
  • 09172013@52
  • 10162013@35
  • 07242013@55
  • 07242013@56
  • 09122013@36
  • 09122013@35
  • 10042013@8
  • 10042013@9
  • 07262013@12
  • 07262013@13
  • 07262013@14

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Specialty Medicine Compounding Pharmacy 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 51 products in this recall →

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