Failed Impurities/Degradation Specifications
Drugs Recalls
Prescription and over-the-counter medications
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
L. Perrigo Company
Failed Impurities/Degradation Specifications
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Global Pharma Healthcare Private Limited
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
L. Perrigo Company
Failed Impurities/Degradation Specifications
Failed Stability Specifications
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22
L. Perrigo Company
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Presence of Particulate Matter: Particulate matter identified as fiber.
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Global Pharma Healthcare Private Limited
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03
L. Perrigo Company
Failed Impurities/Degradation Specifications
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
B. Braun Medical
Lack of assurance of sterility: bags have the potential to leak.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
CGMP Deviation: impurities exceed allowable limits.
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
L. Perrigo Company
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Failed Stability Specifications