Why it was recalled
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Product description
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Lot numbers, UPCs & expiration codes
Lot #: 1918@5, exp. 1/26/2016; 1820@5, exp. 1/12/2016; 1773@5, exp. 1/6/2016; 1665@5, exp. 12/22/2015; 1542@5, exp. 12/1/2015; 1544@6, exp. 12/1/2015.
Where it was sold
Nationwide and Puerto Rico
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-0584-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 4, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pine Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0584-2016, exactly as published.
Show all FDA fields
- City
- Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 72629
- Address
- 100 Colvin Woods Pkwy Suite 300
- Code information
- Lot #: 1918@5, exp. 1/26/2016; 1820@5, exp. 1/12/2016; 1773@5, exp. 1/6/2016; 1665@5, exp. 12/22/2015; 1542@5, exp. 12/1/2015; 1544@6, exp. 12/1/2015.
- Postal code
- 14150-6974
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0584-2016
- Classification
- Class II
- Recalling firm
- Pine Pharmaceuticals, LLC
- Termination date
- Mar 22, 2017
- Reason for recall
- Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2016