Class I - Dangerous
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Golden State Medical Supply
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class I - Dangerous
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
Golden State Medical Supply
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Spectrum Laboratory Products
Class I - Dangerous
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class I - Dangerous
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
Isomeric Pharmacy Solution
Class I - Dangerous
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class I - Dangerous
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Medicap Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class I - Dangerous
Failed Tablet/Capsule Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.