Class I - Dangerous
CGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP Deviations
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Class I - Dangerous
Failed Dissolution Specifications
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX
MOORE'S COMPOUNDING PHARMACY
Class I - Dangerous
Superpotent Drug and Subpotent Drug; potency failures obtained
Class I - Dangerous
CGMP Deviations
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Hospira Inc., A Pfizer Company
Class I - Dangerous
Lack of Sterility Assurance: customer report of leaking bag
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class I - Dangerous
CGMP Deviations
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
SLIMFIT X capsules, packaged in a 60-cont bottle
Jersey Shore Supplements
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Class I - Dangerous
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Accord Healthcare
Class I - Dangerous
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class I - Dangerous
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class I - Dangerous
Superpotent Drug: Product may not meet specifications throughout shelf life.
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Dr. Reddy's Laboratories
Class I - Dangerous
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.