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FDA (Drug enforcement)Recalled 2013-04-18closedclass ii

Sandoz Incorporated: Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 078

Is my product affected?

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

  • Brand AMOXICILLIN

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

What happened

Sandoz Incorporated is recalling certain lots of Amoxicillin Capsules USP 500 mg manufactured in Austria due to potential contamination with fragments of stainless steel wire mesh. The recall affects 8,286 bottles containing 30 capsules and 37,108 bottles containing 500 capsules distributed nationwide. The affected lot codes are CK2003, CK2004, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994, CK3616, and CK3617, with expiration dates in April 2015 or July 2015.

The source document does not specify what action affected consumers should take regarding this recall.

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

Hazard

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Details from the source

Reason for recall: Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. Distribution: Nationwide Quantity: 8286 x 30 ct, 37108 x 500 ct. bottles Lot/code info: CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15

Source

Official record: FDA (Drug enforcement) ↗

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

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