Recalls / Class II
Class IID-1514-2022
Product
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Affected lot / code info
- Lot #s: a) 58366, exp. date 09/26/2022; 60247, exp. date 12/04/2022; b) 54825, exp. date 08/10/2022; 57583, exp. date 08/22/2022; 59343, exp. date 10/30/2022; 60355, exp. date 10/11/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 355 Riverwalk Pkwy, Tonawanda, New York 14150-5837
Distribution
- Quantity
- a) 920 syringes; b) 3263 syringes
- Distribution pattern
- Product was distributed to direct accounts in AL, CA, NC and NY
Timeline
- Recall initiated
- 2022-07-27
- FDA classified
- 2022-09-15
- Posted by FDA
- 2022-09-21
- Terminated
- 2022-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1514-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.