The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-918-2013·Announced 2013-09-04

Avastin Syringes Recalled for Sterility Concerns and Eye Infection Reports

Clinical Specialties Compounding Pharmacy is recalling Avastin syringes due to sterility assurance issues and reports of eye infections.

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 involves reported adverse events of endophthalmitis (eye infections), which aligns with the rubric criterion for 'FDA Class II with hospitalization reports' or significant injury reports.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling 2,190 single-unit dose syringes of Avastin (0.05 ml, 1.25 mg/0.05ml). The recall was initiated due to a lack of assurance of sterility and FDA inspection findings that raised concerns regarding the pharmacy's quality control processes.

The affected product is linked to adverse event reports of endophthalmitis, a type of eye infection. The recall covers specific lots distributed to facilities in Florida, Georgia, Indiana, Louisiana, and South Carolina.

Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Ophthalmic
Hazard
Affected units
2,190

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)

  • Lot #CABDAHAC:39
  • Exp. Date: 5/8/2013
  • Lot #CABDAGAC:58
  • Exp. Date: 4/13/2013
  • Lot #CABDAHAC:77
  • Exp. Date: 4/8/2013
  • Lot #CABDBIAC:86
  • Exp. Date: 4/19/2013
  • Lot #CABDCFAC:29
  • Exp. Date: 4/26/2013
  • Lot #CABDAEAD:26
  • Exp. Date: 5/3/2013
  • Lot #CABDAEAC:47
  • Exp. Date: 5/5/2013
  • Lot #CABDAEAC:58
  • Lot #CABDAFAC:46
  • Exp. Date: 5/6/2013
  • Lot #CABDAIAC:46
  • Exp. Date: 5/9/2013
  • Lot #CABDBCAC:94

Distribution

Distributed in 5 states:

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