February 23, 2000Pharmacia & Upjohn Recall
Solu-Medrol and Solu-Cortef Products
Kalamazoo, MI (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Pharmacia & Upjohn is recalling certain
Solu-Medrol and Solu-Cortef products because of a lack of assurance of sterility.
The recalled Solu-Medrol
Methylprednisolone sodium succinate for injection, USP, comes in 500 mg, single dose vials
with 4 mL, sterile powder (NDC0009-0765-02) and has the Lot numbers of 02DAF and
23DAM EXP 3/31/01.
The recalled Solu- Cortef
Hydrocortisone sodium succinate for injection, USP, comes in 100 mg, single dose vials
with 2mL sterile powder. NDC0009-0900-20 has the Lot number of 29DAM EXP 3/31/04,
NDC0009-0900-13 has the lot number of 48DCU EXP 6/30/04 and NDC0009-0912-05 has the Lot
numbers of 51DCU and 52DCU EXP 6/30/04.
The recalled Solu-Cortef
Hydrocortisone sodium succinate for injection, USP, with the 500 mg, single dose vials
with 4 mL, sterile powder (NDC0009-0912-05) and has the Lot numbers of 51DCU and
52DCU EXP 6/30/04.
According to FDA, about 261,000 vials
were distributed nationwide as well as in the Bahamas, Cayman Islands, Colombia and Japan.
This ongoing Class II recall
was initiated by Pharmacia & Upjohn, by letter dated January 27, 2000. This is
the first public notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-216/218
Notice of this product warning was
sent via email to SafeMail
subscribers February 23, 2000.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.