Avastin Syringes Recalled for Bacterial Contamination
AmEx Pharmacy is recalling 836 Avastin syringes nationwide because testing revealed bacterial contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Pacifico National, Inc. dba AmEx Pharmacy is recalling 836 syringes of Avastin (Bevacizumab) 1.25 mg/0.05 mL. The product is designated for office administration only and was distributed nationwide.
The recall was initiated because the product tested positive for bacterial contamination, indicating a non-sterility issue. The affected lots are 150116B (exp. 04/16/2015), 150119R (exp. 04/19/2015), and 150316H (exp. 06/14/2015).
Healthcare providers and patients should stop using the affected syringes immediately. The FDA has classified this recall as Class I, which is the most serious type of recall.
The recalled product
- Product
- Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
- Manufacturer
- Pacifico National, Inc. dba AmEx Pharmacy
- Category
- Drug — Injectable Medication
- Affected units
- 836
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 (6)
- Lot #: 150116B
- Exp. 04/16/2015
- 150119R
- Exp. 04/19/2015
- 150316H
- Exp. 06/14/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pacifico National, Inc. dba AmEx 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 2 products in this recall →Related recalls
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