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SafetyAlerts
November 1, 2001

Purdue Pharma L.P. Recalls Various OxyContin Labels

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Stamford, CT  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Purdue Pharma L.P. recalls various OxyContin labels.

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

REASON:
Contamination- tablets contain particles of stainless steel and/or were manufactured with an unqualified excipient

MANUFACTURER/RECALLING FIRM:
The P.F. Laboratories, Inc., Totowa, NJ

RECALLED BY:
Purdue Pharma L.P., Stamford, CT, via letter on September 12, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and Argentina, Bolivia, Brazil, Central America, Mexico, Norway, and Peru

QUANTITY:
3,388,083 bottles of 100's and 257,797 blisters of 25 .

RECALL NUMBER, PRODUCT AND CODE:
D-003-2, OxyContin, (oxycodone hydrochloride controlled-release)
tablets,
10 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged
in units of 25 and 100 tablets.

D-004-2, OxyContin, (oxycodone hydrochloride controlled-release)
tablets,
20 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged
in units of 25 and 100 tablets.

D-005-2, OxyContin, (oxycodone hydrochloride controlled-release)
tablets,
40 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged
in units of 25 and 100 tablets.

D-006-2, OxyContin, (oxycodone hydrochloride controlled-release)
tablets,
80 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged
in units of 25 and 100 tablets.

D-007-2, OxyContin, (oxycodone hydrochloride controlled-release)
tablets,
160 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.

There are 388 batches of OxyContin, 10, 20, 40, 80, 160mg Tablets:
10 mg Tablets:
9L91, EXP 28-FEB-05
9M11, EXP 28-FEB-05
9M21, EXP 28-FEB-05
AE81, EXP 31-DEC-04
AE91, EXP 31-DEC-04
AF01, EXP 31-DEC-04
AF81, EXP 31-DEC-04
AF91, EXP 31-DEC-04
AG21, EXP 31-DEC-04
AH41, EXP 28-FEB-05
AH51, EXP 28-FEB-05
AH61, EXP 28-FEB-05
AJ61, EXP 31-JAN-05
AJ71, EXP 31-JAN-05
AJ81, EXP 31-JAN-05
AW81, EXP 31-JAN-05
AW91, EXP 31-JAN-05
AY01, EXP 28-FEB-05
AY11, EXP 28-FEB-05
AY21, EXP 28-FEB-05
AY31, EXP 28-FEB-05
AY41, EXP 28-FEB-05
AY51, EXP 28-FEB-05
AX01, EXP 31-JAN-05
AX04, EXP 31-JAN-05
2L61, EXP 30-NOV-03
2L71, EXP 31-DEC-03
2L81, EXP 31-DEC-03
2W11, EXP 31-DEC-03
2W21, EXP 31-DEC-03
2W31, EXP 31-DEC-03
2Y41, EXP 31-DEC-03
2Y61, EXP 31-DEC-03
2Y71, EXP 31-DEC-03
2Y81, EXP 31-DEC-03
3E51, EXP 31-DEC-03
3E61, EXP 31-JAN-04
CX51, EXP 30-APR-05
CX61, EXP 30-APR-05
WA431, EXP 30-APR-05
WA561, EXP 30-APR-05
WA571, EXP 30-APR-05
8G21, EXP 31-OCT-04
8S1N1, EXP 31-OCT-04
8S2N1, EXP 30-NOV-04
8S9N1, EXP 30-SEP-04
8T0N1, EXP 30-SEP-04
8T1N1, EXP 30-SEP-04
8X31, EXP 31-OCT-04
8X41, EXP 31-OCT-04
8X51, EXP 31-OCT-04
8X91, EXP 30-SEP-04
8Y01, EXP 30-SEP-04
8Y11, EXP 30-SEP-04
9E41, EXP 31-OCT-04
9E51, EXP 31-OCT-04
9E61, EXP 31-OCT-04
9E71, EXP 30-NOV-04
9E81, EXP 30-NOV-04
9K1N1, EXP 31-OCT-04
9K3N1, EXP 31-OCT-04
9P7N1, EXP 30-NOV-04
9P8N1, EXP 30-NOV-04
9P9N1, EXP 30-NOV-04
9R4N1, EXP 30-NOV-04
9R5N1, EXP 30-NOV-04
9S5N1, EXP 30-NOV-04
9S6N1, EXP 30-NOV-04
9S7N1, EXP 30-NOV-04
9V4N7, EXP 30-NOV-04
9W2N1, EXP 30-NOV-04
9E91, EXP 30-NOV-04
9R61, EXP 30-NOV-04
9R62, EXP 30-NOV-04

20mg Tablets:
9R21, EXP 30-NOV-04
9W01, EXP 30-NOV-04
AD62, EXP 31-DEC-04
AD71, EXP 31-DEC-04
AD81, EXP 31-DEC-04
AF11, EXP 31-DEC-04
AF21, EXP 31-DEC-04
AF31, EXP 31-DEC-04
AG81, EXP 31-DEC-04
AG91, EXP 31-DEC-04
AH01, EXP 31-DEC-04
AJ01, EXP 31-DEC-04
AJ11, EXP 31-DEC-04
AJ21, EXP 31-DEC-04
AK21, EXP 31-JAN-05
AK31, EXP 31-JAN-05
AK41, EXP 31-JAN-05
AW51, EXP 31-JAN-05
AW61, EXP 31-JAN-05
AW71, EXP 31-JAN-05
AX31, EXP 31-JAN-05
AX41, EXP 31-JAN-05
BB1N1, EXP 28-FEB-05
BB2N1, EXP 28-FEB-05
BB3N1, EXP 28-FEB-05
AX54, EXP 31-JAN-05
2L2N1, EXP 31-DEC-03
2L3N1, EXP 31-DEC-03
2L4N1, EXP 31-DEC-03
2M11, EXP 30-NOV-03
2M2N2, EXP 30-NOV-03
2M3N1, EXP 30-NOV-03
2M4N2, EXP 30-NOV-03
2M5N1, EXP 31-DEC-03
2T91, EXP 31-DEC-03
2V01, EXP 31-DEC-03
2V11, EXP 31-DEC-03
2W41, EXP 31-DEC-03
2W51, EXP 31-DEC-03
2W61, EXP 31-DEC-03
2X41, EXP 31-DEC-03
2X51, EXP 31-DEC-03
2X61, EXP 31-JAN-04
2X71, EXP 31-DEC-03
2X72, EXP 31-DEC-03
2X81, EXP 31-DEC-03
2X91, EXP 31-DEC-03
2Y01, EXP 31-JAN-04
2Y11, EXP 31-JAN-04
BX71, EXP 30-APR-05
BX81, EXP 30-APR-05
BX91, EXP 30-APR-05
CR61, EXP 31-MAR 05
CR71, EXP 31-MAR-05
CR81, EXP 31-MAR-05
CR91, EXP 30-APR-05
CS01, EXP 30-APR-05
CS11, EXP 30-APR-05
CY11, EXP 30-APR-05
CY21, EXP 30-APR-05
CY31, EXP 30-APR-05
CY41, EXP 30-APR-05
CY51, EXP 30-APR-05
CY61, EXP 30-APR-05
CY71, EXP 30-APR-05
CY81, EXP 30-APR-05
CY91, EXP 30-APR-05
WA401, EXP 30-APR-05
WA411, EXP 30-APR-05
8R1N1, EXP 31-0CT-04
8R2N1, EXP 31-0CT-04
8R3N1, EXP 31-0CT-04
8S31, EXP 31-OCT-04
8S41, EXP 31-OCT-04
8S51, EXP 31-OCT-04
8S61, EXP 31-OCT-04
8S71, EXP 30-NOV-04
8T21, EXP 30-SEP-04
8T31, EXP 30-SEP-04
8T41, EXP 30-SEP-04
8T51, EXP 30-SEP-04
8T61, EXP 30-SEP-04
8T7N1, EXP 31-OCT-04
8T8N1, EXP 30-NOV-04
8T9N1, EXP 30-NOV-04
8X6N1, EXP 30-NOV-04
8X71, EXP 31-OCT-04
8X81, EXP 30-NOV-04
9C31, EXP 31-0CT-04
9C41, EXP 31-OCT-04
9C51, EXP 31-0CT-04
9C91, EXP 31-OCT-04
9D01, EXP 31-OCT-04
9J51, EXP 31-OCT-04
9J61, EXP 31-OCT-04
9J71, EXP 31-OCT-04
9J8N1, EXP 31-OCT-04
9J9N1, EXP 31-OCT-04
9K0N1, EXP 31-OCT-04
9L6N1, EXP 30-NOV-04
9L7N1, EXP 30-NOV-04
9L8N1, EXP 30-NOV-04
9R0N1, EXP 30-NOV-04
9R1N1, EXP 30-NOV-04
9S1N7, EXP 30-NOV-04
9S8N1, EXP 30-NOV-04
9S9N1, EXP 30-NOV-04
9T0N1, EXP 30-NOV-04
9T7N1, EXP 30-NOV-04
9T8N1, EXP 30-NOV-04
9T9N1, EXP 30-NOV-04
9D11, EXP 31-OCT-04

40mg Tablets:
9L31, EXP 31-DEC-04
9V1N1, EXP 30-NOV-04
9V2N1, EXP 30-NOV-04
9V3N1, EXP 30-NOV-04
9W11, EXP 31-DEC-04
AD91, EXP 31-DEC-04
AE01, EXP 31-DEC-04
AE11, EXP 31-DEC-04
AF41, EXP 31-DEC-04
AF51, EXP 31-DEC-04
AF61, EXP 31-DEC-04
AG51, EXP 31-DEC-04
AG61, EXP 31-DEC-04
AG71, EXP 31-DEC-04
AH11, EXP 31-DEC-04
AH21, EXP 31-DEC-04
AH31, EXP 31-DEC-04
AJ91, EXP 31-JAN-05
AX81, EXP 31-JAN-05
AX91, EXP 31-JAN-05
AY61, EXP 28-FEB-05
AY9N1, EXP 31-JAN-05
BA0N1, EXP 31-JAN-05
BA1N1, EXP 28-FEB-05
BA2N1, EXP 31-JAN-05
BA3N1, EXP 31-JAN-05
BA4N1, EXP 31-JAN-05
BD01, EXP 28-FEB-05
BD11, EXP 28-FEB-05
BD21, EXP 28-FEB-05
AK01, EXP 31-JAN-05
2M9N1, EXP 31-DEC-03
2V21, EXP 31-DEC-03
2V31, EXP 31-DEC-03
2V41, EXP 31-DEC-03
2V81, EXP 31-DEC-03
2V91, EXP 31-DEC-03
2W01, EXP 31-DEC-03
2W71, EXP 31-DEC-03
2W81, EXP 31-DEC-03
2W91, EXP 31-JAN-04
CS21, EXP 30-APR-05
CS31, EXP 30-APR-05
CS41, EXP 30-APR-05
CS51, EXP 30-APR-05
CS61, EXP 30-APR-05
CS71, EXP 30-APR-05
8V0N1, EXP 31-OCT-04
8V1N1, EXP 31-OCT-04
8V2N1, EXP 31-OCT-04
8V41, EXP 30-SEP-04
8V51, EXP 30-SEP-04
8V61, EXP 30-SEP-04
8V91, EXP 30-SEP-04
8W01, EXP 30-SEP-04
8W1N1, EXP 31-OCT-04
8W41, EXP 30-SEP-04
8W51, EXP 31-OCT-04
8W61, EXP 31-OCT-04
8W71, EXP 31-OCT-04
8W81, EXP 31-OCT-04
8W91, EXP 31-OCT-04
9C01, EXP 31-OCT-04
9C11, EXP 31-OCT-04
9C21, EXP 31-OCT-04
9D51, EXP 31-OCT-04
9D61, EXP 31-OCT-04
9D71, EXP 31-OCT-04
9D81, EXP 31-OCT-04
9D91, EXP 31-OCT-04
9E01, EXP 31-OCT-04
9K41, EXP 31-OCT-04
9K51, EXP 31-OCT-04
9K61, EXP 31-OCT-04
9L0N1, EXP 31-OCT-04
9L11, EXP 31-OCT-04
9L21, EXP 31-OCT-04
9L4N1, EXP 30-NOV-04
9L5N1, EXP 30-NOV-04
9R7N1, EXP 30-NOV-04
9T1N1, EXP 30-NOV-04
9T2N1, EXP 30-NOV-04
9T3N5, EXP 30-NOV-04
AX71, EXP 31-JAN-05
9D52, EXP 31-OCT-04

80mg Tablets:
9T4N1, EXP 30-NOV-04
9T5N1, EXP 30-NOV-04
9T6N1, EXP 30-NOV-04
9V8N1, EXP 31-DEC-04
9V91, EXP 31-DEC-04
AE51, EXP 31-DEC-04
AE61, EXP 31-DEC-04
AE71, EXP 31-DEC-04
AF71, EXP 31-DEC-04
AG01, EXP 31-DEC-04
AG11, EXP 31-DEC-04
AH71, EXP 31-DEC-04
AH81, EXP 31-DEC-04
AH91, EXP 31-DEC-04
AJ31, EXP 31-DEC-04
AJ41, EXP 31-DEC-04
AJ51, EXP 31-JAN-05
AL11, EXP 31-JAN-05
AL21, EXP 31-JAN-05
AL31, EXP 31-JAN-05
AX61, EXP 28-FEB-05
BA51, EXP 28-FEB-05
BA61, EXP 28-FEB-05
BA71, EXP 28-FEB-05
BA81, EXP 28-FEB-05
AE52, EXP 31-DEC-04
2L5N1, EXP 31-DEC-02
2V61, EXP 31-DEC-02
2V71, EXP 31-DEC-02
2X01, EXP 31-DEC-02
2X11, EXP 31-JAN-03
2X21, EXP 31-JAN-03
CK81, EXP 31-MAR-05
CK91, EXP 31-MAR-05
CL01, EXP 31-MAR-05
CL11, EXP 30-APR-05
WA581, EXP 30-APR-05
WA591, EXP 30-APR-05
WA601, EXP 30-APR-05
8P8N1, EXP 31-OCT-04
8P9N1, EXP 31-OCT-04
8R0N1, EXP 31-OCT-04
8V3N1, EXP 31-OCT-04
8V71, EXP 30-SEP-04
8V81, EXP 30-SEP-04
8W2N1, EXP 30-SEP-04
8W31, EXP 31-OCT-04
8X01, EXP 31-OCT-04
8X11, EXP 31-OCT-04
8X21, EXP 31-OCT-04
9C61, EXP 31-OCT-04
9C71, EXP 31-OCT-04
9C81, EXP 31-OCT-04
9D31, EXP 31-OCT-04
9D41, EXP 31-OCT-04
9E11, EXP 31-OCT-04
9E2N1, EXP 31-OCT-04
9E3N1, EXP 31-OCT-04
9K71, EXP 31-OCT-04
9K81, EXP 31-OCT-04
9K91, EXP 31-OCT-04
9S2N1, EXP 30-NOV-04
9S3N1, EXP 30-NOV-04
9S4N1, EXP 30-NOV-04

160mg Tablets:
9R31, EXP 30-NOV-03
9V51, EXP 30-NOV-03
9V61, EXP 30-NOV-03
AG31, EXP 31-DEC-03
AG41, EXP 31-DEC-03
AX11, EXP 31-JAN-04
AX21, EXP 31-JAN-04
8S81, EXP 30-SEP-03
9D21, EXP 31-OCT-03.

 
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.