FDA Recall
TerminatedTerminated: October 11, 2024Historical recordClass II
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 11, 2024Historical recordClass II
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 11, 2022Historical recordClass II
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
by Edge Pharma, LLC
- Reason
- Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Real Water, Inc.
- Product
- Real Alkalized Water, concentrate. 4 oz. glass bottle . Dri…
- Reason
- FDA was notified of cases of acute liver failure after consumption of Real Water
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Real Water, Inc.
- Product
- Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter…
- Reason
- FDA was notified of cases of acute liver failure after consumption of Real Water
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 13, 2021Historical recordClass II
Snak King Corporation
- Product
- Trader Joe's Restaurant Style White Corn Tortilla Chips; Net…
- Reason
- White Corn Tortilla Chips may contain undeclared milk
- Published
- April 28, 2021
- Distribution
- One customer with locations in AL, AZ, A…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2021Historical recordClass III
Avanti Frozen Foods Private Limited
- Product
- 365 Whole Foods Market Farm Raised Cooked Shrimp 2 lbs/Ready…
- Reason
- One lot of uncooked shrimp was inadvertently packaged as cooked shrimp.
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 19, 2021Historical recordClass II
Tropicana Products, Inc.
- Product
- KeVita Cucumber Rosemary (primary package), 15.2 oz., glass…
- Reason
- Firm initiated a recall because of mislabeling of bottled product inside case.
- Published
- April 28, 2021
- Distribution
- The product was disturbed to the various…
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FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass II
ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass II
Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass II
OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit)
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 9, 2022Historical recordClass I
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91
by Novo Nordisk Inc
- Reason
- Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- Published
- April 21, 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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