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Showing 1281–1300 of 3363 results

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Prolact CR Human Milk Fortifier (Prolacta) – Quarantine Issue (2019)

Shipped lot was un released and under quarantine pending investigation closures.

FDAJan 29, 2019IN, NC• Prolacta Bioscience

Bimatoprost Ophthalmic Solution (Lupin) – impurity specification (2019)

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

FDAJan 28, 2019Nationwide• Lupin Pharmaceuticals Inc.

Clobetasol Propionate Cream (Akorn) – stability failure (2019)

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Class IIILow

FDAJan 25, 2019Nationwide• Akorn Inc

Flour Tortillas (La Canasta) – Packaging ink contamination (2019)

Homestyle Estilo Casero tortillas are being recalled because the packaging ink is contaminating product.

FDAJan 22, 2019AZ, IN, VA• La Canasta Mexican Food Products, Inc.

CoQ10 Capsules (Twenty-First Century) – Mislabeled product (2019)

21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.

FDAJan 22, 2019Nationwide• Twenty-First Century Healthcare, Inc

Vitamin D Supplement (Twenty-First Century) – Mislabeled product (2019)

21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.

FDAJan 22, 2019Nationwide• Twenty-First Century Healthcare, Inc

Melatonin Lozenges (Klaire Labs) – Incorrect filling (2019)

Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

FDAJan 17, 2019IN, KS• ProThera, Inc. dba SFI USA

Clobetasol Propionate Solution (Oxalis Labs) – container defect (2019)

Defective Container; complaints of leakage.

FDAJan 11, 2019Nationwide• Oxalis Labs

Loperamide HCL Tablets (Sun Pharma) – Labeling Mismatch (2018)

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

FDADec 26, 2018OH• Sun Pharmaceutical Industries, Inc.

Temozolomide Capsules (Amerigen) – Failed Dissolution (2018)

Failed Dissolution Specifications

FDADec 20, 2018Nationwide• Amerigen Pharmaceuticals Inc.

Temozolomide Capsules (Amerigen) – Failed Dissolution (2018)

Failed Dissolution Specifications

FDADec 20, 2018Nationwide• Amerigen Pharmaceuticals Inc.

Cosopt Ophthalmic Solution (Akorn) – Failed Stability Test (2018)

Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

FDADec 20, 2018Nationwide• Akorn Inc

Jimmy's Blue Cheese Dressing (Fish House) – mislabeled (2018)

French Blue Cheese salad dressing may be labeled as Original Blue Cheese salad dressing.

FDADec 12, 2018IA, MN, WI• Fish House Dressing, Inc.

Advanced Protection Sunscreen (CBI Labs) – subpotent ingredients (2018)

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

FDADec 10, 2018Nationwide• CBI Laboratories, Inc.

Options Rx Sunscreen (CBI Labs) – subpotent ingredients (2018)

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

FDADec 10, 2018Nationwide• CBI Laboratories, Inc.

Absorica Capsules (Sun Pharmaceutical) – subpotent drug (2018)

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

FDADec 7, 2018Nationwide• Sun Pharmaceutical Industries, Inc.

Amlodipine & Olmesartan (Aurobindo) – Tablet Discoloration (2018)

Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).

FDANov 30, 2018Nationwide• Aurobindo Pharma USA Inc.

Nystatin (VistaPharm) – Impurity Specifications (2018)

Failed Impurities/Degradation Specifications:Out of specification for impurities.

FDANov 30, 2018Nationwide• VistaPharm, Inc.

Aprepitant Capsules (Glenmark) – missing capsule (2018)

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

FDANov 27, 2018Nationwide• Glenmark Pharmaceuticals Inc., USA

Norepinephrine (QuVa Pharma) – incorrect solution (2018)

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

FDANov 21, 2018CA• QuVa Pharma, Inc.

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