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D-0107-2024Class I

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Product type
Drug
Status
Terminated
Report date
2023-11-29
Distribution
Nationwide within the United States
Firm state
TN
Product quantity
1,271,810 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot info

All lots

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.