Bayer HealthCare Pharmaceuticals Inc.

FDA Drug Class I Terminated

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01

November 6, 2023 Bayer HealthCare Pharmaceuticals Inc. 192 bottles units

FDA Drug Class I Terminated

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 579,456 cans units

FDA Drug Class I Terminated

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 738,432 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 4,546,152 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finl

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 579,456 units units

FDA Drug Class II Terminated

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeema

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 4,990,860 cans units

FDA Drug Class I Terminated

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 592,416 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist b

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 3,816,468 cans units

FDA Drug Class II Terminated

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcar

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 1,801,332 cans units

FDA Drug Class II Terminated

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 2,841,012 cans units

FDA Drug Class II Terminated

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 592,416 cans units

FDA Drug Class I Terminated

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 3,816,468 cans units

FDA Drug Class I Terminated

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 2,841,012 cans units

FDA Drug Class I Terminated

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 1

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 4,990,860 cans units

FDA Drug Class II Terminated

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1,

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 738,432 cans units

FDA Drug Class I Terminated

LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 4,546,152 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 2,817,468 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-001

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 77,076 cans units

FDA Drug Class I Terminated

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 2,817,468 cans units

FDA Drug Class II Terminated

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist

October 1, 2021 Bayer HealthCare Pharmaceuticals Inc. 579,456 cans units

FDA Drug Class I Terminated

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on

March 15, 2018 Bayer HealthCare Pharmaceuticals Inc. 188,631 units units

FDA Drug Class II Terminated

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.

February 23, 2018 Bayer HealthCare Pharmaceuticals Inc. 528 units units

FDA Drug Class III Terminated

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577

November 10, 2017 Bayer HealthCare Pharmaceuticals Inc. 104,128 HDPE bottles units

FDA Drug Class II Terminated

Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Ba

March 30, 2017 Bayer HealthCare Pharmaceuticals Inc. 1,067,520 12-count cartons units

FDA Drug Class II Terminated

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed

March 30, 2017 Bayer HealthCare Pharmaceuticals Inc. 56,064 36-count cartons units

FDA Drug Class II Terminated

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by

March 30, 2017 Bayer HealthCare Pharmaceuticals Inc. 24,672 24-count cartons units

FDA Drug Class III Terminated

A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Baye

February 21, 2017 Bayer HealthCare Pharmaceuticals Inc. a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz) units

FDA Drug Class III Terminated

Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

June 13, 2013 Bayer HealthCare Pharmaceuticals Inc. 194.62 kg units

FDA Drug Class III Terminated

Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2

May 31, 2012 Bayer HealthCare Pharmaceuticals Inc. 138,505 vials units

FDA Drug Class II Terminated

Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.

May 8, 2012 Bayer HealthCare Pharmaceuticals Inc. 112.295 kg units