CLASS II Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Bevacizumab 1.25 MG/ Solution for Injection syringes recalled
Pine Pharmaceuticals is recalling Bevacizumab 1.25 MG/ Solution for Injection syringes, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.
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-0050-2024
- FDA event ID
- 93154
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2023
- FDA classified
- 19 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Oct 2023 | Recall initiated by company | |
| 19 Oct 2023 | Classified by FDA | +17 days |
| 25 Oct 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
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 68622, 68620 Exp. Date 10/3/2023; 68632 Exp. Date 10/4/2023; 68699, 68704, 68706 Exp. Date 10/6/2023; 68726, 68740 Exp. Date 10/7/2023; 68784 Exp. Date 10/11/2023; 68843, 68861, Exp. Date 10/13/2023; 68789,68822 Exp. Date 10/12/2023; 68914 Exp. Date 10/17/2023; 68952, 68954, 68980 Exp. Date 10/18/2023; 69105 Exp. Date 10/25/2023; 69731 Exp. Date 11/7/2023; 69991 Exp. Date 11/15/2023;70142 Exp. Date 11/22/2023; 70233 Exp. Date 11/28/2023; 70297, 70264, 70291, 70300 Exp. Date 11/30/2023; 70355 Exp. Date 12/5/2023; 70516, 70513 Exp. Date 12/12/2023;;70659, 70664 Exp. Date 12/19/2023; 70700 Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 11/1/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70403, Exp. Date 12/9/2023; 70513, Exp. Date 2/12/2023; 70569, 70570, 70579, 70571, 70572,70573, 70585, 70503 Exp. Date 12/14/2023; 70692, Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 1/7/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70 692, Exp. Date 12/20/2023, 67538, Exp. Date 10/11/2023; 68535, Exp. Date 10/4/2023; 68611, 68613 Exp. Date 10/3/2023; 68612, 68633, 68637 Exp. Date 10/4/2023; 68638, 68673, 68674,68675, Exp. Date 10/5/2023; 68634, 68699, 68700, 68701, 68702, 68709 Exp. Date 10/6/2023; 68703, 68708, 68728, 68729, 68736, 68737, 68738, 68739, Exp. Date 10/7/2023; 68647, 68757, 68758, 68759, Exp. Date 10/10/2023; 68784, 68785, 68786, 68787, 68788, Exp. Date 10/11/2023; 68821, 68823, 68824, Exp. Date 10/12/2023; 68896, 68897, 68843, 68844, 68850, 68851, 68852, 10/13/2023; 68853 68877, 68878, 68879, 68880, 68886, 68890, 68891 Exp. Date 10/14/2023; 68913, 68915, 68923, Exp. Date 10/17/2023; 68922, 68953,68976, 68980, Exp. Date 10/18/2023; 68977, 68978,68979, 68981, Exp. Date 10/19/2023; 68959,68982, 69016, 69017, 69019, 69012 Exp. Date 10/20/2023; 69018, 69047, 69048, 69049, 69050, 69051, 69052, 69056, 68983, 69042, Exp. Date 10/21/2023; 69072, 69073, 69074, 69075, Exp. Date 10/24/2023; 69102, 69103, 69104, 69105, 69109, Exp. Date 10/25/2023; 69129, 69127, 69077 Exp. Date 10/26/2023; 69142, 69128, Exp. Date 10/27/2023; 69130, 69101, 69131, 69132, 69143, 69144, 69166, 69167, 69168, 69169, 69170, 69171, Exp. Date 10/28/2023; 69726, 69727, Exp. Date 10/31/2023;69746, 69748, 69750, Exp. Date 11/2/2023; 69754, 69755, 69768, 69770, Exp. Date 11/3/2023; 69779, 69751, 69745, 69780, 69781, 69782, 69783, 69784, 69793, Exp. Date 11/4/2023; 69794, 6974, ; 69841, Exp. Date 11/8/2023; 69865, 69866, 69863, 69867, 69796, 69872 Exp. Date 11/9/2023; 69890, 69892,69893, 69894, 69895, 69896, 69897, Exp. Date 11/10/2023; 69928, 69929, 69930,69931,69932, 69933, 69928, 69950, Exp. Date 11/11/2023; 69964, 69868, Exp. Date 11/14/2023; 69965, 69987, 69988, 69990, Exp. Date 11/15/2023; 70031, 70032, 70033, 69963, 70034, Exp. Date 11/16/2023; 70066,70067, Exp. Date 11/17/2023; 69998,70011,69962, 70094, 70095, 69864, 70093 Exp. Date 11/18/2023; 70035, 70113, 70114, 70115, Exp. Date 11/21/2023; 70116, 70138, 70139, 70140, 70147, Exp. Date 11/22/2023; 70163, 70164, 70165, 70166, 70167, 70168, Exp. Date 11/23/2023; 70191, 70193,70194, 70195, 70196, 70197, 70198, 70204, Exp. Date 11/24/2023; 70208, 70211, 70212, 70213, 70214, 70220, 70218, Exp. Date 11/25/2023; 70229, 70231, 70232, 70234, Exp. Date 11/28/2023; 70254, 70255, 70256, 70257, 70261, 70262, 70263, 70277, 70258, 70275 Exp. Date 11/29/2023; 70265, 70314, 70315, 70259,70299 Exp. Date 12/1/2023; 70325, 70326, 70333,70338, 70341 Exp. Date 12/2/2023; 70358, Exp. Date 12/5/2023; 70397, 70398, 70399, 70399, 70409, 70410, 70406, 70404 Exp. Date 12/6/2023; 70324, 70339, 70445, 70450, Exp. Date 12/7/2023; 70462, 70463, 70465, 70466, 70467, Exp. Date 12/8/2023; 70494, 70495, 70497, 70493, 70497, 70501, 70422 Exp. Date 12/9/2023; 70523, 70419, 70514, Exp. Date 12/12/2023;70544, 70549, 70552, 70553, Exp. Date 12/13/2023; 70605,70606, 70340, 70608,70609, 70613, 70619 Exp. Date 12/15/2023; 70635, 70636, Exp. Date 12/16/2023; 70660, 70661, 70662, 70663, 12/19/2023; 70672, 70693, 70694,70695,70696, 70702, Exp. Date 12/20/2023; 70726, 70727, 70728, 70729, 70730, 70744, 70731, Exp. Date 12/21/2023; 70759, 70760, 70762, 70763, Exp. Date 12/22/2023; 70786,70791, 70788, 70789 Exp. Date 12/23/2023; 70835, 70787, 70790, Exp. Date 12/26/2023; 70852, 70853, 70860, 70833 Exp. Date 12/27/2023; 70868, 70869, 70870, 70871, 70874, Exp. Date 12/28/2023; 70832, 70851, Exp. Date 1/4/2024.
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
15 other products · FDA event 93154This product is part of a recall event; the main page for the event is Lidocaine-phenylephrine 1%-1.5% Single Dose Vial recalled.
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 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial 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 III | Bevacizumab 2.5 mg/, Solution for Injection recalled | Pine Pharmaceuticals | Packaging Defects | 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 |