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SafetyAlerts
November 8, 2001

American Pharmaceutical Partners Recall various injection solutions

Melrose Park, IL  (SafetyAlerts) - The Food and Drug Administration (FDA) said that American Pharmaceutical Partners, Inc. is recalling  various injection solutions.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
a) D-010-2, Sodium Bicarbonate Injection, USP, 84 mg/mL, 50 mEq/50 mL, 50 mL single dose vial, NDC #63323-006-50, product code 0650; For IV Use Only, Preservative Free
b) D-011-2, Multi Vitamin Concentrate, 5 mL single dose vial, NDC #63323-042-05, product code 4205; For IV Infusion After Dilution
c) D-012-2, Vinblastine Sulfate Injection, 1 mg/mL, 10 mL multiple dose vial, NDC #63323-278-10, product code 27810; For IV Use Only
d) D-013-2, Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL in 2 mL single dose vial - NDC #63323-165-01, product code 16501 and 5 mL multiple dose vial - NDC #63323-165-05, product code 16505; For IM or IV Use
e) D-014-2, Potassium Phosphates Injection, USP, Phosphorus 3 mM/mL and Potassium 4.4 mEq/mL, 50 mL single dose vial, NDC #63323-086-50, product code 8650; For IV Use Only After Dilution
f) D-015-2, Potassium Acetate Injection, USP, 2mEq/mL, 50 mL single dose vial, NDC #63323-076-50, product code 7650; For IV Use Only After Dilution
g) D-016-2, Clindamycin Injection, USP, 150 mg/mL, 4 mL in 5 mL vial, product code C28204, DIN 021 39286
h) D-017-2, Sodium Chloride (Chlorure De Sodium) Injection, USP, 800 mmol/200 mL, 4 mmol/mL, 200 mL vial, DIN #02139510, product code C88B2; For intravenous infusion after diluation, Pharmacy Bulk Package, Not for Direct Infusion
i) D-018-2, Bacteriostatic Water for Injection, USP, 10 mL
multiple dose vial, NDC #63323-950-10, product code 95106; packaged with the Chorionic Gonadotropin for Injection and used to reconstitute the lyophilized powder
j) D-019-2, Chorionic Gonadotropin for Injection, USP, 10,000 units/mL, 1 mL in 2 mL multiple dose vial (lyophilized), NDC #63323-025-10, product code 25021; For IM Use Only After Reconstitution

Codes:
a) Sodium Bicarbonate Injection, USP, lot 110660, exp.
01/03, lot 110670, exp. 01/03
b) Multi Vitamin Concentrate, lot 110664, exp. 01/03
c) Vinblastine Sulfate Injection, lot 110680, exp. 01/03
d) Dexamethasone Sodium Phosphate Injection, USP, lot 110739, exp. 02/03, lot 110760, exp. 02/03, lot 110767, exp. 02/03
e) Potassium Phosphates Injection, USP, lot 110754, exp. 08/04
f) Potassium Acetate Injection, USP, lot 110766, exp. 02/04
g) Clindamycin Injection, USP, lot 110652, exp. 01/03
h) Sodium Chloride Injection, USP, lot 110710, exp. 02/03
i) Bacteriostatic Water for Injection, USP, lot 110653, exp. 07/04
j) Chorionic Gonadotropin for Injection, USP, lot 110645, exp. 07/03

REASON:
Lack of assurance of sterility

MANUFACTURER/RECALLING FIRM:
American Pharmaceutical Partners, Inc., Melrose Park, IL

RECALLED BY:
Recalling firm, by letters dated 9/28/01 and 10/5/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and Canada

QUANTITY:
504471 vials.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.