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62 catalysts · 33 recall · 12 approval · 9 device 510k · 5 device recall · 2 device pma · 1 grant
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62 catalysts · 33 recall · 12 approval · 9 device 510k · 5 device recall · 2 device pma · 1 grant
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MSD. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: TWI PHARMS. Form: EMULSION. Route: OPHTHALMIC
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: IV (INFUSION)
Sponsor: HISUN PHARM HANGZHOU. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASCENT PHARMS INC. Form: FILM. Route: BUCCAL, SUBLINGUAL
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LIQUID DAYQUIL 12/8oz — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN MIGRAINE 2'S- 25 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Swan, White Clear Alcohol, 50%, 16oz, 12 count — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Aleve 1's, 60 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
MOTRIN 2'S DISP.- 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN 2'S DISP.- 30 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 — Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. — Status: Ongoing
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
PEPTO BISMOL 32CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each — Reason: cGMP deviations. — Status: Ongoing
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Reason: Presence of Particulate Matter. — Status: Ongoing
NYQUIL COLD & FLU -32CT/2PK — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Claritin, 20 Count, UPC: 655708016305 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01 — Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10. — Reason: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. — Status: Ongoing
Bayer 2Pk- 25 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
PEPCID COMPLETE - 25CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
DAYQUIL COLD & FLU, 32CT/2PK — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Benadryl, 25'S 2PK Box, UPC 815556020316 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4 — Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. — Status: Ongoing
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Product code: SHB. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QFX. Advisory committee: Neurology. Type: Traditional