Class II · Moderate risk Ongoing
PEPCID COMPLETE - 25CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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Class II · Moderate risk Ongoing
PEPTO BISMOL 32CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
NYQUIL COLD & FLU -32CT/2PK
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
MOTRIN 2'S DISP.- 50CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
EXCEDRIN MIGRAINE 2'S- 25 CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
EXCEDRIN 2'S DISP.- 30 CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
LIQUID DAYQUIL 12/8oz
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
DAYQUIL COLD & FLU, 32CT/2PK
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Claritin, 20 Count, UPC: 655708016305
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Bayer 2Pk- 25 CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Benadryl, 25'S 2PK Box, UPC 815556020316
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets…
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Aleve 1's, 60 CT
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM…
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class I · High risk Ongoing
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
Reason CGMP Deviations: product found to contain lead.
Class II · Moderate risk Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC…
Reason Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class III · Low risk Ongoing
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San…
Reason Failed PH Specifications
Class II · Moderate risk Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato…
Reason Failed Disintegration Specifications: above the time expected.
Class III · Low risk Ongoing
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed…
Reason Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II · Moderate risk Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd…
Reason Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880…
Reason Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705…
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC…
Reason Presence of particulate matter - Glass like particles.