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FDA (Drug enforcement)Recalled 2012-11-09closedclass ii

Ranbaxy Inc.: Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbax

Is my product affected?

Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.

  • Brand ATORVASTATIN CALCIUM

Check against the official notice below — it lists the full affected range.

What happened

Ranbaxy Inc. is recalling certain batches of Atorvastatin Calcium Tablets 40 mg in both 90-tablet and 500-tablet bottles because they may contain small glass particulates. The recall affects 157,026 bottles distributed nationwide and in Puerto Rico. The affected lots are specific batches of the 40 mg strength with expiration dates of July 31, 2014 or August 31, 2014, identified by their lot numbers.

The source record does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Details from the source

Reason for recall: Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Distribution: Nationwide and PR Quantity: 157,026 Bottles Lot/code info: a) 40 mg 90 count, Lot #s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count, Lot #s: 2437956, 2437957, 2440675, Exp 08/31/2014.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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