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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches.
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
The recalled burn relief gel is packaged in a blue box with white letters "Burn Relief" and red letters "Burn Relief Gel". The brand name is Assured™. Inside the box is a blue and white tube labeled "Burn Relief Gel" and measuring approximately 5 inches long by 1 inch wide and weighs about 0.7 ounces (20 grams). The packaging contains the UPC bar code: 6 39277 09311 0.
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.