Why it was recalled
Non-Sterility: Product tested positive for bacterial contamination.
Product description
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Lot numbers, UPCs & expiration codes
Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015
Where it was sold
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-0870-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 20, 2015
- FDA report date
- Jun 1, 2016
- Quantity
- 836 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pacifico National, Inc. dba AmEx Pharmacy
Original FDA data
Every field from FDA enforcement report D-0870-2016, exactly as published.
Show all FDA fields
- City
- Melbourne
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 73560
- Address
- 1515 Elizabeth St Ste J
- Code information
- Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015
- Postal code
- 32901-3000
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0870-2016
- Classification
- Class I
- Recalling firm
- Pacifico National, Inc. dba AmEx Pharmacy
- Product quantity
- 836 syringes
- Termination date
- Mar 9, 2017
- Reason for recall
- Non-Sterility: Product tested positive for bacterial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 20, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 25, 2016