Coast Quality Pharmacy Recalls MAA Kits Due to Sterility Concerns
Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in a medical product, are classified as Severe (Score 4).
Plain-English summary
Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits (for the preparation of Tc99m MAA). The product is a lyophilized powder in a 10 mL glass vial containing aggregated and non-aggregated human serum albumin and sodium acetate. The recall is being conducted because of a lack of assurance of sterility.
The affected lots are MAA-171219BM (best use date 4/19/18) and MAA-180226BM (best use date 06/26/18). The products were distributed to Alabama, California, Florida, Michigan, South Carolina, and Texas.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
- Manufacturer
- Coast Quality Pharmacy LLC
- Category
- Medical Device — Diagnostic Kits
- Hazard
- Affected units
- 52
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 (2)
- Lot: MAA-171219BM BUD: 4/19/18
- MAA-180226BM BUD: 06/26/18
Distribution
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