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

FDA recall notice · announced May 16, 2018 · Coast Quality Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: AL, CA, FL, MI, SC, TX
Lot/code information: Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18
Quantity: 52 vials
Status: Terminated
Products in this recall event:
- 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 vi (D-0801-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.