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Microbial Contamination Prompts Recall

United Exchange Corp. has launched a voluntary recall impacting 20 lots of eye wash solution after discovering the potential for microbial contamination.

The manufacturer supplied products to both Rugby Laboratories (Rugby EyeWash) and Major Pharmaceuticals (Major EyeWash).

What prompted the recall? United Exchange received a complaint.

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“Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection,” Rugby Laboratories noted in a statement.

If in possession of one of the impacted products, immediate cessation of use is recommended.

 

Product

Lot

Expiration

NDC

Major EyeWash

G15905

October 2018

0904-6491-20

Major EyeWash

G15906

October 2018

0904-6491-20

Major EyeWash

G15907

October 2018

0904-6491-20

Major EyeWash

G15910

November 2018

0904-6491-20

Major EyeWash

G15911

November 2018

0904-6491-20

Major EyeWash

G15912

November 2018

0904-6491-20

Major EyeWash

G16901

January 2019

0904-6491-20

Major EyeWash

G16902

January 2019

0904-6491-20

Major EyeWash

G16903

January 2019

0904-6491-20

Major EyeWash

G16905

February 2019

0904-6491-20

Major EyeWash

G16906

February 2019

0904-6491-20

Major EyeWash

G16907

February 2019

0904-6491-20

Major EyeWash

G16910

March 2019

0904-6491-20

Major EyeWash

G16911

March 2019

0904-6491-20

Rugby EyeWash

G15908

October 2018

0536-1083-97

Rugby EyeWash

G15909

November 2018

0536-1083-97

Rugby EyeWash

G16904

January 2019

0536-1083-97

Rugby EyeWash

G16908

February 2019

0536-1083-97

Rugby EyeWash

G16912

March 2019

0536-1083-97

Rugby EyeWash

G16913

March 2019

0536-1083-97

 

The products were distributed nationwide to hospitals and pharmacies.

Rugby was recently involved in another recall due to the potential for contamination. A nationwide recall of oral liquid docusate sodium (Diocto Liquid) was launched in July due to possible contamination with Burkholderia cepacia. 

 

--Stephanie Vaccaro

 

Reference:

Rugby Laboratories. United Exchange Corp. issues voluntary nationwide recall of eye wash/eye irrigating solutions distributed by Major Pharmaceuticals and Rugby Laboratories due to microbial contamination [press release]. www.fda.gov. September 6, 2016.

 

 

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