🍔 Food 💊 Drugs 🏥 Medical Devices
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 Class II

Reason: Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Tolmar, Inc. 20220711 Terminated
Distributed: distributed to 1 consignee in KY.
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Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Class I

Reason: Presence of particulate matter: particulate identified as a beetle.

Pfizer Inc. 20220713 Terminated
Distributed: USA Nationwide
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Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 Class III

Reason: Failed Dissolution Specifications

Eco Lips, Inc 20220629 Terminated
Distributed: CA
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Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 Class III

Reason: Failed Dissolution Specifications

Eco Lips, Inc 20220629 Terminated
Distributed: CA
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Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90 Class II

Reason: Failed Dissolution Specifications

Jubilant Cadista Pharmaceuticals, Inc. 20220718 Terminated
Distributed: Nationwide within the United States
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Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90 Class II

Reason: Failed dissolution specifications.

Jubilant Cadista Pharmaceuticals, Inc. 20220718 Terminated
Distributed: Nationwide within the United States
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Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV Class I

Reason: Labeling: Missing label: Label missing from some prefilled pens.

Mylan Pharmaceuticals Inc 20220705 Terminated
Distributed: Product was distributed nationwide within the United States
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Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88. Class II

Reason: Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

SUN PHARMACEUTICAL INDUSTRIES INC 20220627 Terminated
Distributed: Nationwide in the USA
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Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202. Class III

Reason: Labeling: Missing label: the product tube was missing a label and contained a different formulation.

The Procter & Gamble Company 20220708 Completed
Distributed: Washington State
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Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30 Class II

Reason: Superpotent Drug: Out of specification assay result was obtained during stability testing.

Teva Pharmaceuticals USA Inc 20220629 Terminated
Distributed: Nationwide in the USA
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