FDA Recall
Terminated
Historical recordClass I
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
by Cipla USA, Inc.
- Reason
- Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Global Pharma Healthcare Private Limited
- Reason
- 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.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
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.
by Global Pharma Healthcare Private Limited
- Reason
- Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Global Pharma Healthcare Private Limited
- Reason
- 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.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
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.
by Global Pharma Healthcare Private Limited
- Reason
- Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
by ACCORD HEALTHCARE, INC.
- Reason
- Presence of Particulate Matter: Particulate matter identified as fiber.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
by ACCORD HEALTHCARE, INC.
- Reason
- Presence of Particulate Matter: Particulate matter identified as fiber.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by B. Braun Medical Inc.
- Reason
- Lack of assurance of sterility: bags have the potential to leak.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Moisture Limits: Water (moisture) content above the approved product specifications.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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