Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Ph...
FDA Drug Recall #D-0050-2024 — Class II — October 2, 2023
Recall Summary
| Recall Number | D-0050-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 2, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pine Pharmaceuticals, LLC |
| Location | Tonawanda, NY |
| Product Type | Drugs |
| Quantity | 2862 Syringes |
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Lot / Code Information
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.
Other Recalls from Pine Pharmaceuticals, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0059-2024 | Class II | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose... | Oct 2, 2023 |
| D-0057-2024 | Class II | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe,... | Oct 2, 2023 |
| D-0058-2024 | Class II | Moxifloxacin in Balanced Salt Solution 400 mcg/... | Oct 2, 2023 |
| D-0055-2024 | Class II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.... | Oct 2, 2023 |
| D-0061-2024 | Class II | Calcium chloride Solution for Intravenous Injec... | Oct 2, 2023 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.