Quad Mix Injectable Recalled Due to Sterility Concerns
The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.
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 a lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable, 5 mL, Rx Only. The recall covers all sterile products compounded by the pharmacy within their expiry dates.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. The specific hazard is a lack of assurance of sterility.
This recall is limited to North Carolina. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
- Manufacturer
- Compounding Centre At Blue Ridge
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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 (1)
- All Lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Compounding Centre At Blue Ridge 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 5 products in this recall →Related recalls
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Similar recalls
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