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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999

Novartis Pharmaceuticals Recalls Miacalcin Nasal Spray

Suffern, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Novartis Pharmaceuticals Corporation is recalling Miacalcin Nasal Spray because of discoloration, low pH, and subpotency potential due to embedded ferrous contamination in a portion of glass vials used in production.

Corrected June 29 (New information in red)

PRODUCT
Miacalcin Nasal Spray (Calcitonin-Salmon), 200 IU/dose, in 2 mL vials, Rx for the treatment for postmenopausal osteoporosis in females greater than five years postmenopause, with low bone mass relative to healthy premenopausal females. NDC 0078-0311-90.

Recall #D-254-9.

CODE
Lot #355A9473 EXP Date - Dec / 2001
Lot #206Z4722 EXP Date - Aug / 2000
Lot #236Z5438 EXP Date - Oct / 2000
Lot #362B9718 EXP Date - Jan / 2002
Lot #362B9719 EXP Date - Jan / 2002
Lot #362B9971 EXP Date - Jan / 2002
Lot #200Z4716 EXP Date - Jul / 2000
Lot #201Z4717 EXP Date - Jul / 2000
Lot #202Z4718 EXP Date - Aug / 2000
Lot #203Z4719 EXP Date - Aug / 2000
Lot #204Z4720 EXP Date - Aug / 2000
Lot #205Z4721 EXP Date - Aug / 2000
Lot #207Z4723 EXP Date - Aug / 2000
Lot #208Z4724 EXP Date - Aug / 2000
Lot #210Z4725 EXP Date - Aug / 2000
Lot #213Z4726 EXP Date - Sep / 2000
Lot #214Z5066 EXP Date - Sep / 2000
Lot #215Z5067 EXP Date - Sep / 2000
Lot #216Z5068 EXP Date - Sep / 2000
Lot #323A6800 EXP Date - May / 2001
Lot #323A6802 EXP Date - May / 2001
Lot #323A6804 EXP Date - May / 2001
Lot #323A6806 EXP Date - May / 2001
Lot #323A6808 EXP Date - May / 2001
Lot #323A6810 EXP Date - May / 2001
Lot #324A6491 EXP Date - May / 2001
Lot #324A6494 EXP Date - May / 2001
Lot #324A6495 EXP Date - May / 2001
Lot #324A6611 EXP Date - May / 2001
Lot #324A6613 EXP Date - May / 2001

This recall covers all of the firms product lots distributed from from 11/19/97 thru 05/20/99 identified under the same numbers NDC 0078-0311-90), and Lots: (Miacalcin Nasal Spray 200 IU Carton of 1's):
Lot #209Z2255 EXP Date - Aug / 2000
Lot #324A6483 EXP Date - May / 2001

and all of the firms manufactured product lots identified under NDC 0078-9149-01.

MANUFACTURER
Novartis Pharmaceuticals Corporation, Basel, Switzerland.

RECALLED BY
Novartis Pharmaceuticals Corporation, Suffern, New York, by letter on May 4, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
New Jersey, Tennessee, Indiana, Texas, Washington state, Oregon, California, Massachusetts, Illinois, Missouri, Florida, Puerto Rico, Vermont, North Dakota, New York, Michigan, Kentucky, Pennsylvania, New Mexico.

QUANTITY
131,837 cartons were distributed.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.