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Safety Alerts
September 14, 1999

Carton Mix-Up Causes Recall of Ophthalmic Solutions from Optopics Laboratories

Fairton, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Optopics Laboratories, a Division of NutraMax Products is recalling Ophthalmic Solutions because of a Unit carton mix-up.   Correctly labeled Phenylephrine HCL units packaged in outer cartons labeled for artificial tears.

a) Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, in 15 mL bottles , Rx ophthalmic drug, a vasoconstrictor and mydriatic prepared as a sterile topical ophthalmic solution.(NDC 0364-736-72);
b) Artificial Tears, Lubricant Ophthalmic Solution (Polyvinyl Alcohol 1.4%), 15 mL bottles, OTC ophthalmic drug for the temporary relief of discomfort due to minor irritations of the eye (NDC 0364-2427).

Recall #D-415/416-9.  Class II

Lot numbers: 8H011 EXP 2/00, 8H121 EXP 2/00, 8H321 EXP 2/00, 8I231 EXP 3/00, and 8J211 EXP 3/00.
Optopics Laboratories, Division of NutraMax Products, Fairton, New Jersey.

Manufacturer, by telephone and fax on July 23, 1999. Firm-initiated recall ongoing.


69,264 unit packages were distributed; firm estimated that 5,000 units remained on market at time of recall initiation.

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