November 30, 1999Steris
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
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.
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