Recalls / Class III
Class IIID-0531-2023
Product
Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1
- Affected lot / code info
- Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 355 Riverwalk Pkwy, N/A, Tonawanda, New York 14150-5837
Distribution
- Quantity
- 932 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-27
- FDA classified
- 2023-04-13
- Posted by FDA
- 2023-04-19
- Terminated
- 2023-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0531-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.