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More Than 64,000 Bottles of an Antibiotic Recalled

The US Food and Drug Administration (FDA) announced the recall of amoxicillin for oral suspension.

What prompted the Class III recall? West-Ward Pharmaceutical noted the product strength was not listed.

The products, manufactured by Hikma Pharmaceuticals in Jordan, were distributed nationwide.

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Presentation

Lot

Expiration

NDC

Quantity

400 mg/5 mL, 100 mL (when reconstituted)

AS1413A

November 2018

00143-9887-01

32,006 bottles

400 mg/5 mL, 100 mL (when reconstituted)

AS1414A

November 2018

00143-9887-01

32,198 bottles

 

In March, the company notified the FDA that a number of presentations of cefotaxime sodium (Claforan) injection were on allocation due to increased demand.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of September 28, 2016. www.fda.gov. Accessed September 29, 2016.

 

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