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SafetyAlerts
May 2, 2002

Alpharma USPD Has Recalled Cromolyn Sodium Nasal Solution

Baltimore, MD (SafetyAlerts) - The Food and Drug Administration (FDA) said that Alpharma USPD has recalled Cromolyn Sodium Nasal Solution USP.

PRODUCT
Cromolyn Sodium Nasal Solution USP, Each spray delivers 5.2 mg cromolyn sodium,(40 mg/mL), 13 mL (100 sprays) and 26 mL (200 sprays) plastic spray pumps containers, Manufactured by Alpharma USPD under the following labels:
Alpharma Cromolyn Sodium Nasal Solution USP
Pfizer BenaMist
Major Cromolyn Sodium Nasal Solution USP
Perfect Choice Cromolyn Sodium Nasal Solution USP
Kroger Cromolyn Sodium Nasal Solution USP
Rite Aid Cromolyn Sodium Nasal Solution USP
Walgreens Wal-Crom
Longs Nasal Allergy Symptom Controller
Eckerd Cromolyn Sodium Nasal Solution USP
Equate Cromolyn Sodium Nasal Solution USP
Good Neighbor Cromolyn Sodium Nasal Solution USP
Leader Nasal Allergy Control Spray
Savon/Osco Cromolyn Sodium Nasal Solution USP
Valu-Rite Nasal Allergy Symptom Controller
CVS Cromolyn Sodium Nasal Solution USP
Family Pharmacy Nasal Allergy Symptom Controller
Quality Choice Cromolyn Sodium Nasal Solution USP
AAFES Nasal Allergy Symptom Controller
Discount Drug Mart Cromolyn Sodium Nasal Solution USP
Recall # D-239-2.
CODE
Lot Number Expiry Date
RA1009 31-Jul-02
RA1010 31-Aug-03
RB1068 31-Jul-03
RB1069 31-Jul-03
RB1069 31-Aug-03
RC1136 30-Sep-03
RC1191 30-Sep-03
RC1192 30-Sep-03
RC1193 31-Oct-03
RC1194 31-Oct-03
RH1442 31-Oct-03
RH1444 31-Oct-03
RH1445 31-Oct-03
RH1447 30-Nov-03
RH1448 30-Nov-03
RH1449 30-Nov-03
RH1450 30-Nov-03
RH1451 30-Nov-03
RH1452 30-Nov-03
RH1453 31-Dec-03
RH1454 31-Dec-03
RH1455 31-Dec-03
RH1456 31-Dec-03
RH1457 31-Dec-03
RH1458 31-Dec-03
RH1459 31-Jan-04
RH1460 31-Jan-04
RH1461 31-Jan-04
RH1462 31-Jan-04
RH1463 31-Oct-03
RH1464 31-Oct-03
RH1465 31-Dec-03
RH1466 31-Oct-03
RH1467 31-Oct-03
RH1468 30-Nov-03
RH1469 31-Dec-03
RS0847 31-Jul-03.

RECALLING FIRM/MANUFACTURER
Alpharma USPD, Baltimore, MD, by letter on March 19, 2002.
Firm initiated recall is ongoing.

REASON
Good Manufacturing Practice Deviations (CGMP): Product was manufactured under the same conditions that yielded contaminated (microbial) product.

VOLUME OF PRODUCT IN COMMERCE
1,423,008 units.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


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.