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Class II: temporary or reversible health riskTerminated

Pharmalucence Kit for the Preparation of Technetium TC-99M Recall

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count)

Pharmalucence, Inc. · Billerica, MA

Risk level
Class II
Reported by FDA
May 23, 2018
Recall ID
D-0815-2018
Check your lot numberHow we source this data

Summary

Pharmalucence recalled Kit for the Preparation of Technetium TC-99M starting Apr 10, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0815-2018 on May 23, 2018. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

Product description

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Lot numbers, UPCs & expiration codes

Part Number MEM05 and MEB30 both with expiry date 12/2018

Where it was sold

US Nationwide

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-0815-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 10, 2018
FDA report date
May 23, 2018
Quantity
157 units (5 count) and 464 units (30 count)
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmalucence, Inc.

Original FDA data

Every field from FDA enforcement report D-0815-2018, exactly as published.

Show all FDA fields
City
Billerica
State
MA
Status
Terminated
Country
United States
Event ID
79802
Address
29 Dunham Rd
Code information
Part Number MEM05 and MEB30 both with expiry date 12/2018
Postal code
01821-5729
Report date
May 23, 2018
Product type
Drugs
Recall number
D-0815-2018
Classification
Class II
Recalling firm
Pharmalucence, Inc.
Product quantity
157 units (5 count) and 464 units (30 count)
Termination date
Oct 31, 2018
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Distribution pattern
US Nationwide
Recall initiation date
Apr 10, 2018
Initial firm notification
Letter
Center classification date
May 15, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0815-2018, published May 23, 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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