CLASS III Drug recall · Reported 19 Apr 2023 · FDA Enforcement Report
Bevacizumab 2.5 mg/, Solution for Injection recalled
Pine Pharmaceuticals is recalling Bevacizumab 2.5 mg/, Solution for Injection in, silicone free slip tip syringe, each, distributed nationwide in the US. The recall was initiated on 27 Mar 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0531-2023
- FDA event ID
- 91972
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Mar 2023
- FDA classified
- 13 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Mar 2023 | Recall initiated by company | |
| 13 Apr 2023 | Classified by FDA | +17 days |
| 19 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Which lots are affected?
Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pine Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Foscarnet Sodium 2.4mg/ solution recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Endophth Kit (Vancomycin 1mg/ - Ceftazidime 2.25mg recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |
Other Bevacizumab recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bevacizumab 1.75 mg/ - syringe, Intravitreal Total Volume recalled | RC Outsourcing | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab, 1.25 mg/ MJ Syringe Intravitreal Injection recalled | Pacifico National | Sterility | PR |
| Drug | CLASS II | Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled | Pacifico National | Sterility | PR |
| Drug | CLASS II | Bevacizumab 784 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |