Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Sy...
FDA Drug Recall #D-0531-2023 — Class III — March 27, 2023
Recall Summary
| Recall Number | D-0531-2023 |
| Classification | Class III — Low risk |
| Date Initiated | March 27, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pine Pharmaceuticals, LLC |
| Location | Tonawanda, NY |
| Product Type | Drugs |
| Quantity | 932 syringes |
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
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
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
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.