Why it was recalled
GMP deviation; Sr-82 levels exceeded alert limit specification
Product description
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
Lot numbers, UPCs & expiration codes
Lot numbers 09101-121251 and 09101-121391
Where it was sold
Nationwide and United Kingdom
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-1684-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 1, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 54 generators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-1684-2012, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62866
- Address
- 107 College Rd E
- Code information
- Lot numbers 09101-121251 and 09101-121391
- Postal code
- 08540-6623
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1684-2012
- Classification
- Class II
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 54 generators
- Termination date
- Mar 18, 2013
- Reason for recall
- GMP deviation; Sr-82 levels exceeded alert limit specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
- Distribution pattern
- Nationwide and United Kingdom
- Recall initiation date
- Jun 1, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2012