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Showing 1081–1100 of 1571 results

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Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.

FDAAug 8, 2022Nationwide• Akorn, Inc

PrednisoLONE Oral Solution (Akorn) – Incomplete Seals (2022)

Defective Container: Product has incomplete induction seals.

Class IIModerate

FDAAug 1, 2022Nationwide• Akorn, Inc

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

Class IIILow

FDAJul 11, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Aspirin Dipyridamole Capsules (Glenmark) – Capsule Breakage (2022)

Failed Tablet/Capsule Specification : Capsule breakage

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Daytrana Patch (Noven) – Delivery System Defect (2022)

Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Class IIModerate

FDAJun 24, 2022Nationwide• Noven Pharmaceuticals Inc

Lidocaine Arthritis Sport Cream (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Good Sense Hemorrhoid Treatment (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

DRX Fiber Capsules (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Aspirin Chewable Tablets (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Acetaminophen PM Caplets (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Aspercreme Lidocaine Cream (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Softsoap Anti-Bacterial Liquid Soap (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Aleve Back Muscle Caplets (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Stye Eye Ointment (Family Dollar) – Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OI... (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Triple Antibiotic Ointment (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Motrin IB Caplets (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Luxury Hygiene Hand Sanitizer 8 FL OZ (Family Dollar) – temperature storage issue (2022)

cGMP deviations: product stored outside of labeled temperature requirements.

Class IIModerate

FDAMay 17, 2022Nationwide• Family Dollar Stores, Llc.

Luxury Hygiene Hand Sanitizer (Family Dollar) – temperature storage issue (2022)

cGMP deviations: product stored outside of labeled temperature requirements.

Class IIModerate

FDAMay 17, 2022Nationwide• Family Dollar Stores, Llc.

Daytrana (Noven) – Delivery System Defect (2022)

Defective Delivery System: customer complaints exceeded respective action limits.

Class IIModerate

FDAMay 6, 2022Nationwide• Noven Pharmaceuticals Inc

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