FDA Recall
Terminated
Historical recordClass II
vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.
by The Ritedose Corporation
- Reason
- CGMP deviation: product released prior to supplier approval.
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ZB Importing LLC
- Product
- Ziyad Brand Jameed Soup Starter sold in a 35.2 fluid ounce t…
- Reason
- Does not declare the major food allergen "milk"
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
by New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
by Kramer Laboratories, Inc.
- Reason
- CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
by Kramer Laboratories, Inc.
- Reason
- CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
by ALEMBIC PHARMACEUTICALS, INC.
- Reason
- Defective Delivery System
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of Foreign Substance: Metal embedded in a tablet.
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
by Sagent Pharmaceuticals
- Reason
- Lack of Assurance of Sterility
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
by Sagent Pharmaceuticals
- Reason
- Lack of Assurance of Sterility
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
by Sagent Pharmaceuticals
- Reason
- Lack of Assurance of Sterility
- Published
- August 2, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
by Glenmark Therapeutics, Inc.
- Reason
- Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- July 26, 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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