Ranbaxy recalls
FDA enforcement reports naming Ranbaxy Inc. as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Aug 12, 2015
- Aug 12, 2015Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx…Drug · Ranbaxy Inc.Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.Class II
- Mar 5, 2014Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured…Drug · Ranbaxy Inc.Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.Class II
- Feb 20, 2013Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy,…Drug · Ranbaxy Inc.Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.Class III
- Feb 20, 2013Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes)Drug · Ranbaxy Inc.Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.Class III
- Dec 5, 2012Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottl…Drug · Ranbaxy Inc.Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.Class II
- Dec 5, 2012Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for:…Drug · Ranbaxy Inc.Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.Class II
- Dec 5, 2012Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for:…Drug · Ranbaxy Inc.Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.Class II
- Nov 28, 2012Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured…Drug · Ranbaxy Inc.Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.Class II
- Jul 11, 2012Balnetar Therapeutic Tar Bath, Coal Tar USP 2Drug · Ranbaxy Inc.Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.Class III