FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
by HERON THERAPEUTICS, INC.
- Reason
- Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilbur's Of Maine Chocolate Confections
- Product
- Wilbur's of Maine Milk Chocolate Covered Blueberries
- Reason
- Product contains undeclared almonds.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Crown Prince, Inc
- Product
- Crown Prince Quality Natural Seafood Smoked Baby Clams Hand…
- Reason
- Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
by Strides Pharma Inc.
- Reason
- Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
by AVKARE Inc.
- Reason
- Labeling: Label Error on Declared Strength
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
by CIPLA
- Reason
- Lack of Assurance of Sterility: Complaints received of defective container closure.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- 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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