Drug recall: Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in…
Class III FDA enforcement event 91972. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Pine Pharmaceuticals, LLC started this drug recall on 27 Mar 2023. The firm address in the FDA record is in Tonawanda, NY. FDA put the recall in Class III. FDA event 91972 has 1 product record. The first FDA enforcement report date is 19 Apr 2023. The record gives the status Terminated, with the termination date 1 Jun 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA
Recalling firm
Pine Pharmaceuticals, LLC, Tonawanda, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0531-2023 | 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… | 932 syringes | Class III | Terminated | 19 Apr 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2023
- 281
- Share of these events in Class III
- 26%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Oct 2023 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 River | Drug | Class II | 16 |
| 22 Dec 2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded | Drug | Class II | 1 |
| 27 Jul 2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 | Drug | Class II | 1 |
| 5 Mar 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy | Drug | Class III | 1 |
| 4 Nov 2015 | Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods | Drug | Class II | 4 |
Official channels
- FDA enforcement report D-0531-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91972. https://recallregister.com/fda/iii/91972/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA
- What quantity of product is in FDA event 91972?
- The FDA record gives this quantity:
932 syringes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 26% of the 281 drug events that started in 2023 are in Class III.