Class I - Dangerous
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Sandoz Incorporated
Cross Contamination With Other Product: Imipramine
Class I - Dangerous
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class I - Dangerous
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class I - Dangerous
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class I - Dangerous
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Class I - Dangerous
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Presence of Particulate Matter: Found during examination of retention samples.
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.