CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report
Macroaggregated albumin (MAA) kit recalled by Coast Quality Pharmacy
Coast Quality Pharmacy is recalling Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and, distributed in Alabama, California, Florida, Michigan, South Carolina, Texas. The recall was initiated on 26 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0801-2018
- FDA event ID
- 80005
- Recalling firm
- Coast Quality Pharmacy, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2018
- FDA classified
- 10 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Apr 2018 | Recall initiated by company | |
| 10 May 2018 | Classified by FDA | +14 days |
| 16 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
AL, CA, FL, MI, SC, TX
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18
Where was it sold?
AL, CA, FL, MI, SC, TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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