FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
by CareFusion 213, LLC
- Reason
- Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
by CareFusion 213, LLC
- Reason
- Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 9, 2021Historical recordClass I
GOLDEN MEDAL MUSHROOM INC
- Product
- Enoki Mushroom Product of Korea Net Wt. 200 g/7.05 oz. UPC:…
- Reason
- Michigan Department of Agriculture and Rural Development sampled product and results found Listeria monocytogenes.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- April 28, 2021
- Distribution
- Nationwide
View recall →
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: 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
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
View recall →
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 →
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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