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Consumer Product Safety Improvement Act of 2008 (CPSIA) and Poison Prevention Packaging Act of 1970 (PPPA) 16 CFR Part 1700

Karalex Pharma, LLC is committed to ensuring compliance with the CPSIA’s requirements for Certificates of Conformity Testing and Third Party Testing. The CPSIA of 2008 requires every manufacturer of a product that is subject to the Child-Resistance Packaging requirements of the PPPA of 1970, must issue a certification assuring that the product complies with all applicable rules. The following is a list of prescription products distributed by Karalex Pharma, LLC and which are subject to the provisions of the CPSIA. Each product listed below complies with the special packaging requirements of the CPSIA and the design of the packaging was tested as indicated in each product certificate of compliance. To receive a copy of the CPSIA certificate for any of the products listed below, please contact Karalex Pharma at 866.306.0240.

Product/Strength Package Size NDC # Certified By Testing Company Report Number/Date


Cephalexin Capsules

250mg

100 42043-140-01 Rexam Closures Perritt Laboratories on file

250mg

500 42043-140-05 Rexam Closures Perritt Laboratories on file

500mg

100 42043-141-01 Rexam Closures Perritt Laboratories on file

500mg

500 42043-141-05 Rexam Closures Perritt Laboratories on file

Cephalexin Oral Suspension

125mg/5ml

100ml 42043-142-38 Rexam Closures Perritt Laboratories on file

125mg/5ml

200ml 42043-142-58 Rexam Closures Perritt Laboratories on file

250mg/5ml

100ml 42043-143-38 Rexam Closures Perritt Laboratories on file

250mg/5ml

200ml 42043-143-58 Rexam Closures Perritt Laboratories on file

Naratriptan Tablets, USP

1mg

9s 42043-130-09 Rexam Closures Perritt Laboratories on file

2.5mg

9s 42043-131-09 Rexam Closures Perritt Laboratories on file
           

Testing Laboratory Information:
Perritt Laboratories
145 South Main Street
Post Office Box 147
Hightstown, NJ 08520
(609) 443-4848

 

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