Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
Class I - Dangerous
Microbial Contamination of Non-sterile Product
Class I - Dangerous
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I - Dangerous
Defective delivery system
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I - Dangerous
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
Sun Pharmaceutical Industries
Class I - Dangerous
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
Lack of Assurance of Sterility
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Altera Handset NDC 83490-0678-05 56 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.