Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle…
Reason CGMP Deviations
Is Lansoprazole recalled?
25 FDA recalls mention Lansoprazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lansoprazole.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India…
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx…
Reason FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx…
Reason FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk Ongoing
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid…
Reason Out of specification results observed in dissolution during long term stability testing.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited…
Reason Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx…
Reason Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk Terminated
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by…
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by…
Reason Failed Dissolution Specification
Class III · Low risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only…
Reason Subpotent Drug.
Class II · Moderate risk Terminated
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC…
Reason CGMP deviations
Class III · Low risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only…
Reason Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled…
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Lansoprazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count…
Reason Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability…
Class II · Moderate risk Terminated
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200…
Reason Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for…
Class II · Moderate risk Terminated
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan…
Reason Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
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