Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Annora Pharma Private Limited
Class I - Dangerous
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Cardinal Health 200
Class I - Dangerous
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class I - Dangerous
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
The Harvard Drug Group
Class I - Dangerous
Defective container; inadequately sealed blister packaging.
Class I - Dangerous
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Rising Pharma Holding
Class I - Dangerous
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class I - Dangerous
CGMP Deviations
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
New Life Pharma
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
ACME UNITED
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Stability Data Does Not Support Expiry Date.
Class I - Dangerous
Stability Data Does Not Support Expiry Date.
Class I - Dangerous
CGMP Deviations