FDA Recall
TerminatedTerminated: September 24, 2024Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
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
TerminatedTerminated: September 24, 2024Historical 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
TerminatedTerminated: July 13, 2023Historical 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
OngoingHistorical 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
TerminatedTerminated: August 18, 2023Historical 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
TerminatedTerminated: August 23, 2023Historical 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
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Water - Sterilized (Export Canada) 2 fl oz reclose…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Stage 1 (Export Colombia) 2 fl oz reclose able plast…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Special Care 2 fl oz reclose able plastic bottle Pa…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Total Comfort 2 fl oz reclose able plastic bottle P…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Neosure 2 fl oz reclose able plastic bottle Package…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care Sensitive with Nipples 2 fl oz reclos…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care Sensitive 2 fl oz reclose able plasti…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care/Similac 360 Total Care Sensitive Disc…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care 2 fl oz reclose able plastic bottle…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Pedialyte Unflavored (Export to Canada) 2 fl oz plastic recl…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic r…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
TerminatedTerminated: January 12, 2024Historical 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
TerminatedTerminated: January 11, 2024Historical 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 →
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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