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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number MEM05 and MEB30 both with expiry date 12/2018
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pharmalucence, Inc.
- Reason for Recall:
- Failed Stability Specifications
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Part Number MEM05 and MEB30 both with expiry date 12/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0815-2018
Related Recalls
Class I - Dangerous
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class I - Dangerous
Presence of Particulate Matter; particulate found in retain samples