Tonawanda, NY, United States
Pine Pharmaceuticals, LLC recalls
5 recalls recorded since 2018, most recently on 2 October 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 2 October 2023
- Terminated
- 15 May 2024
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0059-2024, D-0057-2024, D-0058-2024, D-0061-2024, D-0062-2024, D-0056-2024, D-0060-2024, D-0053-2024, D-0064-2024, D-0054-2024, D-0051-2024, D-0063-2024 and 4 more
- Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- and 8 more product lines
Terminated Class III Drugs
- Recall started
- 27 March 2023
- Terminated
- 1 June 2023
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 Pharma
Terminated Class II Drugs
- Recall started
- 22 December 2022
- Terminated
- 4 May 2023
- Reason
- CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- Distribution
- Nationwide to medical facilities.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0130-2023
- Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
Terminated Class II Drugs
- Recall started
- 27 July 2022
- Terminated
- 19 October 2022
- Reason
- Lack of Assurance of Sterility
- Distribution
- Product was distributed to direct accounts in AL, CA, NC and NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1514-2022
- Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6
Terminated Class III Drugs
- Recall started
- 5 March 2018
- Terminated
- 23 April 2018
- Reason
- Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
- Distribution
- NY only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0607-2018
- Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.