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SafetyAlerts
November 30, 1999

Steris Laboratories Dexamethasone Sodium Phosphate Injection Recalled

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories, Inc. is recalling certain lots of Dexamethasone Sodium Phosphate Injection because there was insufficient test methods for product release to assure identity, strength, purity, and quality.

The recalled product is Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, in 30 ml vial and is, an adrenocortical steriodal anti-inflammatory drug, intended for administration by intravenous, intramuscular, intra-articular, intra-lesional, and soft tissue routes.  The product was distributed under the following labels:

NDC 0402,-0807-30 (Steris Laboratories, Inc.)
NDC 0364-6681-56 (Schein Pharmaceutical, Inc.)
NDC 0182-3007-66 (Zenith Goldline)
NDC 12671-807-30 (Ace Surgical Supply).

This ongoing Class II recall was initiated by the company on August 20, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

Over 81,000 units were distributed nationwide and bear the lot numbers and expiration dates of:
98B790 EXP 9/99
98E010 EXP 9/99
98E020 EXP 10/99

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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.

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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.