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Showing 3841–3860 of 14370 results

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Omeprazole Capsules (Breckenridge) – impurity specifications (2021)

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

Class IIModerate

FDAMar 11, 2021Nationwide• Breckenridge Pharmaceutical, Inc

ZOMA-Jet 10 Demonstration Kit (Ferring) – Injector Defect (2021)

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Class IIModerate

FDAMar 11, 2021Nationwide• Ferring Pharmaceuticals Inc

ZOMA-Jet 5 Demonstration Kit (Ferring) – Injector Defect (2021)

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Class IIModerate

FDAMar 11, 2021Nationwide• Ferring Pharmaceuticals Inc

Phenylephrine Injection (Sagent) – sterility risk (2021)

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

Class IIModerate

FDAMar 11, 2021Nationwide• Sagent Pharmaceuticals Inc

Sodium Chloride Irrigation (ICU Medical) – particulate matter (2021)

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Class IIModerate

FDAMar 9, 2021Nationwide• ICU Medical Inc

Tremfya Injection (Cardinal Health) – temperature abuse (2021)

Temperature Abuse

FDAMar 9, 2021AL, LA, MS +1 more• Cardinal Health Inc.

Gabapentin Oral Solution (Akorn) – impurity specifications (2021)

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

Class IIModerate

FDAMar 8, 2021Nationwide• Akorn, Inc.

Live Better Vegan Vitamin D3 (CVS Health) – Label Claim Issue (2021)

Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.

FDAMar 8, 2021Nationwide• New Generation Wellness Inc.

Vegan Vitamin D3 (New Generation Wellness) – Label Claim Issue (2021)

Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.

FDAMar 8, 2021Nationwide• New Generation Wellness Inc.

Romidepsin Injection (Teva) – impurity specifications (2021)

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

FDAMar 4, 2021Nationwide• Teva Pharmaceuticals USA

Nortriptyline Capsules (Direct Rx) – ingredient deviation (2021)

cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.

Class IIModerate

FDAMar 2, 2021GA• Direct Rx

Menopur (Ferring) – pH specification failure (2021)

Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

FDAMar 2, 2021Nationwide• Ferring Pharmaceuticals Inc

Acetaminophen Tablets (A-S Medication) – labeling mixup (2021)

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

FDAMar 2, 2021Nationwide• A-S Medication Solutions LLC.

Progesterone Capsules (Dr. Reddy's) – dissolution failure (2021)

Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.

Class IIModerate

FDAFeb 26, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Imatinib Mesylate Tablets (Dr. Reddy's) – Poisoning Risk (2021)

This recall involves blister packages of prescription medications. The name and strength of the medication, "For Institutional Use only," "Rx Only," lot number and expiration date are printed on the outside of the package as well as on the individual blister units. The Dr. Reddy's logo and NDC number are printed on the outside of the package. The recalled medications include the following: Recalled Prescription Drugs NDC Numbers Carton Configurations Lot Numbers Expiration Dates Imatinib Mesylate Tablets 100 mg 43598-344-31 3 blister cards of 10 tablets H2000138 2022-0630 Imatinib Mesylate Tablets 400 mg 43598-345-31 3 blister cards of 10 tablets H2000127 2022-0630 Pregabalin Capsules 50 mg 43598-292-66 5 blister cards of 10 capsules T900876 2021-0630 Pregabalin Capsules 75 mg 43598-293-66 5 blister cards of 10 capsules T901021 2021-0731 Pregabalin Capsules 100 mg 43598-294-66 5 blister cards of 10 capsules T901022 2021-0731 Pregabalin Capsules 150 mg 43598-295-66 5 blister cards of 10 capsules T901023 2021-0731 Sevelamer Carbonate Tablets 800 mg 55111-789-11 4 blister cards of 25 tablets T801003, T000009, T900221 2020-1031, 2021-1231, 2021-0228 Tadalafil Tablets 5 mg 43598-575-31 3 blister cards of 10 tablets T000376 2022-0131 Tadalafil Tablets 20 mg 43598-573-31 3 blister cards of 10 tablets T000425 2022-0228

CPSCFeb 25, 2021Nationwide• Dr. Reddy's Laboratories, Ltd., of India

Cequa Ophthalmic Solution (Sun Pharma) – subpotent (2021)

Subpotent

FDAFeb 22, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Methylprednisolone Tablets (Jubilant Cadista) – Illegible Label (2021)

Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

FDAFeb 19, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Daytrana 15mg (Noven) – Delivery System Defect (2021)

Defective Delivery System: Out of specification for mechanical peel.

Class IIModerate

FDAFeb 19, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 10mg (Noven) – Delivery System Defect (2021)

Defective Delivery System: Out of specification for mechanical peel.

Class IIModerate

FDAFeb 19, 2021Nationwide• Noven Pharmaceuticals Inc

Atorvastatin Calcium 40mg (Dr. Reddy's) – Impurity Specifications (2021)

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

FDAFeb 19, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

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