Teva Pharmaceuticals USA, Inc.: Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Is my product affected?

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

• Brand AMOXICILLIN

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

What happened

Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin for Oral Suspension, USP 400mg/5mL in two bottle sizes: 75ml bottles (NDC 0093-4161-78) and 100mL bottles (NDC 0093-4161-73). The recall affects 758,554 bottles distributed nationwide due to yellow to brown discoloration of amoxicillin powder found on the inner foil seal of the bottles. The affected lots have expiration dates ranging from June 2014 to October 2014.

The specific lot numbers being recalled are identified for both bottle sizes, with NDC 0093-4161-78 including lots 35426081A through 35427228A, and NDC 0093-4161-73 including lots 35426631A through 35426642B. The source document does not specify a remedy or instructions for affected consumers.

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

Hazard

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

Details from the source

Reason for recall: Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. Distribution: Nationwide Quantity: 758,554 bottles Lot/code info: a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.

Source

Official record: FDA (Drug enforcement) ↗

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

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