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17 catalysts · 12 device 510k · 5 recall
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17 catalysts · 12 device 510k · 5 recall
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05. — Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01 — Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. — Status: Ongoing
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52 — Reason: LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. — Status: Ongoing
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2 — Reason: CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit — Status: Ongoing
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 — Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit — Status: Ongoing
Product code: DHB. Advisory committee: Immunology. Type: Traditional
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Special
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: PNN. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional