Status
Terminated
Drug Enforcement D-0531-2023
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Classification
Class III
Report Date
April 19, 2023
Termination Date
June 1, 2023
Product Information
- Product description
- 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
- Product quantity
- 932 syringes
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pine Pharmaceuticals, LLC
- Address
-
355 Riverwalk Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0531-2023
- Event ID
- 91972
- Recall initiation date
- March 27, 2023
- Center classification date
- April 13, 2023
- Code info
- Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
- More code info
- —