FDA Recall
Terminated
Historical recordClass II
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Stability data does not support expiry.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Subpotent drug.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Stability data does not support expiry.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Stability data does not support expiry.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Stability data does not support expiry.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Subpotent drug.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
by Pharmakon Pharmaceuticals
- Reason
- Stability data does not support expiry.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895.
by Perrigo Company PLC
- Reason
- Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.
by Perrigo Company PLC
- Reason
- Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- Published
- February 3, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
by Mayne Pharma Usa
- Reason
- Lack of Assurance of Sterility: Failed preservative effectiveness test
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
by Grato Holdings, Inc.
- Reason
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Published
- January 27, 2016
- 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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