FDA Recall
OngoingHistorical recordClass I
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
by Exela Pharma Sciences LLC
- Reason
- Presence of Particulate Matter: Silicone
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
by Exela Pharma Sciences LLC
- Reason
- Presence of Particulate Matter: Silicone
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 14, 2024Historical recordClass III
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
by NCS Healthcare of Kentucky Inc
- Reason
- Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 14, 2024Historical recordClass III
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
by NCS Healthcare of Kentucky Inc
- Reason
- Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 5, 2024Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 15, 2025Historical recordClass I
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 15, 2025Historical recordClass I
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 8, 2025Historical recordClass II
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
by Family Medical Supply Inc
- Reason
- cGMP Deviations
- Published
- November 22, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- Cotton Candy with M&Ms, ice-cream base, M&M's, artificial fl…
- Reason
- Undeclared allergens: Milk, peanuts, and soy. Undeclared color additive: FD&C blue #1, blue #2, red #3.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- BUBBLEGUM GUMMYBEAR, ice-cream base, artificial flavor. Dist…
- Reason
- Undeclared allergens: Milk and tree nuts. Undeclared color additive: FD&C blue #1.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- ORANGE CREAMCYCLE, Filtered water, natural flavoring, artifi…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C red #5, red #6, blue #1, blue #5, blue #6.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- GUANAVANA (SOURSOP/GUANABANA), ice-cream base, natural flavo…
- Reason
- Undeclared allergen: Milk.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- CHUNKY MANGO, ice-cream base, natural flavoring, artificial…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- KEY LIME PIE, PARADISE FLAVORS, 9601 Overseas Hwy, Marathon…
- Reason
- Undeclared allergens: Milk, soy, and wheat. Undeclared color additives: FD&C yellow #5, blue #1, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- COCONUT/COCO ice cream mix, natural flavors, artificial flav…
- Reason
- Undeclared allergens: Milk and tree nut.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- Avocado, ice-cream base, Natural flavor, artificial coloring…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- CHOCOLATE, ice-cream base, chocolate powder, natural flavor…
- Reason
- Undeclared allergens: Milk and soy.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- EZQUIMAL, ice-cream base, natural flavoring, chocolate cover…
- Reason
- Undeclared allergens: Milk, tree nuts, peanuts, and soy. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- MAGNUM, ice-cream base, natural flavoring, 4 OZ. DISTRIBUTED…
- Reason
- Undeclared allergens: Milk, tree nuts, peanuts, and soy. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- MAMEY with sweet and condensed milk, PARADISE FLAVORS, 4 OZ…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C red #5, red #6, red #40, yellow #5.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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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