🍔 Food 💊 Drugs 🏥 Medical Devices
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets Class II

Reason: CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. 20230331 Ongoing
Distributed: Nationwide within the United States
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Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets. Class II

Reason: CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. 20230331 Ongoing
Distributed: Nationwide within the United States
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Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471. Class II

Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Seatex LLC 20230419 Ongoing
Distributed: FL, GA, TX
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Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90) Class II

Reason: CGMP deviations.

PD-Rx Pharmaceuticals, Inc. 20230406 Terminated
Distributed: Nationwide in the US.
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Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90) Class II

Reason: CGMP deviations.

PD-Rx Pharmaceuticals, Inc. 20230406 Terminated
Distributed: Nationwide in the US.
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Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90 Class II

Reason: CGMP deviations.

PD-Rx Pharmaceuticals, Inc. 20230406 Terminated
Distributed: Nationwide in the US.
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Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90) Class II

Reason: CGMP deviations.

PD-Rx Pharmaceuticals, Inc. 20230406 Terminated
Distributed: Nationwide in the US.
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Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30 Class II

Reason: CGMP deviations.

PD-Rx Pharmaceuticals, Inc. 20230406 Terminated
Distributed: Nationwide in the US.
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Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA Class III

Reason: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

Bryant Ranch Prepack, Inc. 20230420 Ongoing
Distributed: Nationwide in the USA
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Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1 Class II

Reason: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

Sun Pharmaceutical Industries Ltd. 20230419 Terminated
Distributed: Nationwide in the USA
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