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SafetyAlerts
November 30, 1999

29 Prescription Products by Marsam Pharmaceuticals Recalled

Cherry Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Marsam Pharmaceuticals is recalling various prescription products because there was insufficient equipment cleaning.  The equipment residues detected talc and aliphatic hydrocarbon.

This ongoing Class II recall was initiated by the company on July 1 and 7, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

All lot codes of the following recalled products are affected:

1. Dobutamine Injection, USP, 250 mg, 20 mL Single Dose Vial
2. Etopside Injection, USP, 100 mg, 5 mL Multiple Dose Vial
3. Etopside Injection, USP, 150 mg, 7.5 mL Multiple Dose Vial
4. Etopside Injection, USP, 500 mg, 25 mL Multiple Dose Vial
5. Etopside Injection, USP, 1 g, 50 mL Multiple Dose Vial
6. Fentanyl Citrate Injection, USP, 1000 mcg, 20 mL Single Dose Vial
7. Fentanyl Citrate Injection, USP, 2500 mcg, 50 mL Single Dose Vial
8. Heparin Sodium Injection, USP, 1000 USP units/mL, 5 mL Ampul
9. Lorazepam Injection, USP, 1 mg/0.5mL syringe
10. Lorazepam Injection, USP, 4 mg/mL , 1 mL syringe
11. Lorazepam Injection, USP, 2 mg/mL , 1 mL and 10 mL Multiple Dose Vials
12. Lorazepam Injection, USP, 4 mg/mL , 1 mL and 10 mL Multiple Dose Vials
13. Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple Dose Vial
14. Morphine Sulfate Injection, USP, 100mg/4mL, 4 mL Single Use Vial
15. Morphine Sulfate Injection, USP, 250/10mL, 10 mL Single Use Vial
16. Morphine Sulfate Injection, USP, 500 mg/20mL, 20 mL Single Use Vial
17. Morphine Sulfate Injection, USP, 1g/40mL, 40 mL Single Use Vial
18. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 500 mg/10mL, 10 mL Single Use Vial
19. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 1g/20mL, 20 mL Single Use Vial
20. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 2g/40mL, 40 mL Single Use Vial
21. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 100mg/4mL, 4 mL Single Use Vial
22. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 250mg/10mL, 10 mL Single Use Vial
23. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 500mg/20mL, 10 and 20 mL Single Use Vial
24. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 1g/40mL, 40 mL Single Use Vial
25. Neostigmine Methylsulfate Injection, USP, 0.5mg/mL, 10 mL Multiple Dose Vial
26. Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10 mL Multiple Dose Vial
27. Tobramycin Sulfate Injection, USP, 20 mg, 2 mL vial
28. Tobramycin Sulfate Injection, USP, 80 mg, 2 mL vial
29. Tobramycin Sulfate Injection, USP, 40 mg/mL, 30 mL Multiple Dose Vial.

An unknown quantity of the recalled product was distributed Nationwide and in Canada.

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.