FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
by KVK-Tech, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
by VistaPharm LLC
- Reason
- Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
by Church & Dwight Inc
- Reason
- Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
by Dollar Tree Distribution, Inc.
- Reason
- CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
by Imprimis NJOF, LLC
- Reason
- Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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