Manufacturing Recalls Lamprene(r) Soft Gelatin Capsules
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999
West Point, PA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Merck Manufacturing Division, Division of Merck
and Company, Inc. is recalling Hydrocortone Phosphate Injection (Hydrocortisone Sodium
Phosphate USP Injection), 50 mg per ml, because the pH results in stability testing were
lower than specification
The recalled Hydrocortone
Phosphate Injection is a prescription packaged in 2-ml single dose vials
Lot numbers 0037H, 0693H, 0920E, and 0944D. All lots expire March 2001.
Merck Manufacturing Division, Division of Merck and Company, Inc., West Point,
Manufacturer, by letter dated February 16, 1999. Firm-initiated recall ongoing.
29,276 vials were distributed.