Drug product

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

D-0107-2024

October 31, 2023

Class I

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 93339
Status: Terminated
Classification: Class I
Quantity: 1,271,810 bottles
Official record key: drug-enforcement:D-0107-2024

Official wording

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Code information: All lots

Distribution pattern: Nationwide within the United States

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.