Lack of Assurance of Sterility: There are also CGMP Deviations.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
Isomeric Pharmacy Solution
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Synergy Rx
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Mylan Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
Endo Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
Mckesson Packaging Services
Class I - Dangerous
Presence of Foreign Substance: foreign material found in the bulk inventory.
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class I - Dangerous
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Class I - Dangerous
Failed dissolution specifications - low dissolution results at S3 stage.