FDA Recall
Terminated
Historical recordClass II
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
by Custopharm, Inc.
- Reason
- Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
by XELLIA PHARMACEUTICALS USA, LLC
- Reason
- Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
by XELLIA PHARMACEUTICALS USA, LLC
- Reason
- Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Lidl Preferred Selection-Red Wine Cheddar - 7 oz.
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Lidl Preferred Selection-Irish Stout Cheddar - 7 oz.
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- 1. Cahills Ireland Original Irish Porter 5lbs.Waxed Deli Whe…
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Cahills Ireland Whiskey Cheese - 5lb. Waxed Deli Wheel
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
by Teligent Pharma, Inc.
- Reason
- Correct Labeled Product Mispack
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
by Teligent Pharma, Inc.
- Reason
- Correct Labeled Product Mispack
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specification: Some tablets are shaved
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- 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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