FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
by Viatris Inc
- Reason
- Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
by ICU Medical Inc
- Reason
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
by Par Formulations Private Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
by ImprimisRx NJ
- Reason
- Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
by Viatris Inc
- Reason
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hammond's Candies Since 1920 II, LLC
- Product
- Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6…
- Reason
- Peanut Butter Chocolate Chip Cookies mispacked in Salted Caramel Cookies Box creating undeclared peanut allergen.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
by Genentech Inc
- Reason
- Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of Foreign Substance
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
by Golden State Medical Supply Inc.
- Reason
- Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
by VistaPharm, Inc.
- Reason
- cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
by AuroMedics Pharma LLC
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Chai Box
- Product
- THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glas…
- Reason
- Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
- Published
- November 2, 2022
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Chai Box
- Product
- THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles UP…
- Reason
- Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
- Published
- November 2, 2022
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle,…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 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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