OSHA Inspection: VINTAGE PHARMACEUTICALS INC.

Issued

Oct 16, 2002

Abate by

Oct 29, 2002

Penalty

Initial $2,000 · Current $2,000

General-duty citation text

North Carolina General Statute 95-129(1) of the Occupational Safety
and Health Act of North Carolina:  The employer did not furnish
employment and a place of employment which were free from
recognized hazards that were causing or likely to cause death or
serious physical harm to employees in that employees were exposed
to:
a)blending area - employees were mixing trihexyphenidyl
hydrochloride (HCl) an anticholinergic medication. On
July 21 and July 22, 2002, an employee began experiencing
symptoms of an overdose exposure.  According to medical
records the employee was confused, hallucinating, his
mouth was dry, pupils were dilated, he had blurred
vision, nauseated, decreased appetite, abdominal
cramping, and difficulty starting his urine stream.
According to mental health research when a patient is
overdosed they can experience such symptoms as central
nervous system depression, confusion, hallucination,
psychosis, ataxia, muscle weakness, dry mouth, mydriasis,
blurred vision, palpitations, shock, convulsions,
respiratory arrest, anhidrosis, hyperthermia, glaucoma,
and constipation.  In addition personal air sampling was
taken during the batch process when the trihexyphenidyl
HCl and microcrystalline cellulose were added to the
SWECO.  The employee exposure over 117 minutes was 7.399
mg/m3.  The area sample over 111 minutes was 7.534 mg/m3.
These values are the time weighted average for the
sampling time.
Engineering/Administrative Controls
This hazard can be controlled with an increased capture
velocity of the local ventilation. Also, the mixing and
sifting SWECO operation could possibly be enclosed in a
box with glove attached to the enclosure.  Additionally,
personal protective equipment should be worn that does
not allow oral, dermal, or inhalation exposures. Personal
protective equipment should include properly donned
respirators for dust, face shields, shoe covers, goggles,
gloves, and tyvek suits.  The employees should also
change clothes prior to breaks and when leaving the
plant.g

Issued

Oct 16, 2002

Abate by

Oct 22, 2002

Issued

Oct 16, 2002

Abate by

Oct 22, 2002

Issued

Oct 16, 2002

Abate by

Oct 22, 2002

Issued

Oct 16, 2002

Abate by

Oct 22, 2002