FDA Recall
Terminated
Historical recordClass II
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
by B. Braun Medical Inc
- Reason
- Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Trader Joe's Company
- Product
- Trader Joe s Southwest Salad (SKU 56077) 9 oz.
- Reason
- L. mono contamination
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Trader Joe's Company
- Product
- Trader Joe s Elote Chopped Salad Kit (SKU 74768) 11.94 oz.
- Reason
- L. mono contamination
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Trader Joe's Company
- Product
- Trader Joe s Cilantro Salad Dressing (SKU 36420) Perishable…
- Reason
- L. mono contamination
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
House of Coffee Beans, Inc
- Product
- Coffee 5 pound bags, 2 pound bags, 1 pound bags, 12 ounce ba…
- Reason
- potential allergen contact with almonds, pecans and coconut.
- Published
- March 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
by Stason Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: results slightly under spec at at 9-months.
- Published
- March 13, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
by Contract Pharmaceuticals Limited Canada
- Reason
- Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Published
- March 13, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
by Contract Pharmaceuticals Limited Canada
- Reason
- Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Published
- March 13, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
TRUONG GIANG WAREHOUSE
- Product
- Golden Owl Dried Mango 7 oz (200g) UPC 816710-024461. Packag…
- Reason
- Undeclared sulfites
- Published
- March 13, 2024
- Distribution
- Distributed to FL, GA, IL, MA, MI, MN, M…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
by Bausch Health Companies, Inc.
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- March 6, 2024
- 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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