Class I - Dangerous
CGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Cross Contamination with other products: trace amounts of lidocaine
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Shilpa Medicare Limited
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Lack of CGMPs:
Class I - Dangerous
Failed Dissolution Specifications
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
Golden State Medical Supply
Class I - Dangerous
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Teligent Pharma
Class I - Dangerous
Superpotent and Subpotent; low and high assay results
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
US Pharmaceuticals
Class I - Dangerous
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class I - Dangerous
Failed Dissolution Specifications: Out of specification for dissolution.
Class I - Dangerous
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Class I - Dangerous
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
InvaTech Pharma Solutions
Class I - Dangerous
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class I - Dangerous
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
Teligent Pharma
Class I - Dangerous
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Failed Tablet/Capsule Specification
Class I - Dangerous
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class I - Dangerous
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
Fusion Health and Vitality
Class I - Dangerous
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class I - Dangerous
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Heritage Pharmaceuticals
Class I - Dangerous
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A