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Class II: temporary or reversible health riskTerminated

Coast Quality Pharmacy Macroaggregated albumin Recall

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and no…

Coast Quality Pharmacy LLC · Tampa, FL

Risk level
Class II
Reported by FDA
May 16, 2018
Recall ID
D-0801-2018
Check your lot numberHow we source this data

Summary

Coast Quality Pharmacy recalled Macroaggregated albumin starting Apr 26, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0801-2018 on May 16, 2018. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

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

Lot numbers, UPCs & expiration codes

Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18

Where it was sold

AL, CA, FL, MI, SC, TX

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0801-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 26, 2018
FDA report date
May 16, 2018
Quantity
52 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Coast Quality Pharmacy LLC

Original FDA data

Every field from FDA enforcement report D-0801-2018, exactly as published.

Show all FDA fields
City
Tampa
State
FL
Status
Terminated
Country
United States
Event ID
80005
Address
5710 Hoover Blvd
Code information
Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18
Postal code
33634-5339
Report date
May 16, 2018
Product type
Drugs
Recall number
D-0801-2018
Classification
Class II
Recalling firm
Coast Quality Pharmacy LLC
Product quantity
52 vials
Termination date
Jun 4, 2020
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
AL, CA, FL, MI, SC, TX
Recall initiation date
Apr 26, 2018
Initial firm notification
Letter
Center classification date
May 10, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0801-2018, published May 16, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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