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SafetyAlerts
April 11, 2002

Alpharma USPD Has Recalled Epinephrine Mist Kit, Epinephrine Inhalation Aerosol

Baltimore, MD  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Alpharma USPD has recalled Epinephrine Mist Kit, Epinephrine Inhalation Aerosol.

PRODUCT
Epinephrine Mist Kit, Epinephrine Inhalation Aerosol, USP, 5.5 mg/mL 1/2 Fl. Oz., Kit contains nebulizer/actuator packaged with vial. Recall # D-221-2.

Epinephrine Mist-Epinephrine Inhalation Aerosol USP Refill, 5.5 mg/mL, packaged in 0.5 ounce plastic coated glass vials, 1 vial per box, 24 boxes/carton. Recall # D-222-2.

CODE
Kit with Inhaler (1/2 oz)
Lot Number Expiration Date
RB0166 28-Feb-02
RB0170 28-Feb-02
RB0171 31-Mar-02
RB1200 31-Jan-03
RB1201 31-Jan-03
RB1204 28-Feb-03
RB1205 28-Feb-03
RB1207 28-Feb-03
RB1208 28-Feb-03
RC0176 30-Apr-02
RC1209 28-Feb-03
RC1213 31-Mar-03
RD0178 30-APR-02
RD0180 31-Mar-02
RD0182 30-Mar-02
RD0183 30-Mar-02
RF1414 30-Mar-03
RH0543 30-Jun-02
RH0544 31-Jul-02
RH0547 31-Jul-02
RH0548 31-Jul-02
RJ1669 30-Jun-03
RJ1671 30-Jun-03
RJ1672 30-Jun-03
RK0551 31-Aug-02
RK0552 31-Aug-02
RK0553 31-Aug-02
RK0689 30-Sep-02
RK1676 31-Jul-03
RK1677 31-Jul-03
RK1680 31-Aug-03
RL0690 30-Sep-02
RL0691 30-Sep-02
RN0698 31-Oct-02
RN0699 31-Oct-02
RN0700 31-Oct-02
RP0834 31-Oct-02
RP0835 31-Oct-02
RS0840 31-Jan-03
RS0841 31-Jan-03

Refill (1/2 oz)
Lot Number Expiration Date
RB0167 28-Feb-02
RB0168 28-Feb-02
RB0169 28-Feb-02
RB1202 28-Feb-03
RB1203 28-Feb-03
RB1206 28-Feb-03
RC0172 31-Mar-02
RC0173 03-Jan-00
RC0177 28-Feb-02
RC1210 31-Mar-03
RC1211 31-Mar-03
RC1212 31-Mar-03
RC1214 31-Mar-03
RD0179 31-Mar-02
RD0181 30-Mar-02
RD0410 31-Mar-03
RD1405 30-APR-03
RD1406 31-May-03
RD1407 31-May-03
RD1408 31-May-03
RD1409 31-May-03
RF1410 31-Mar-03
RF1412 31-Mar-03
RF1413 31-Mar-03
RH0542 30-Mar-02
RH0545 31-Jul-02
RH0546 31-Jul-02
RH0549 31-Aug-02
RH0550 31-Aug-02
RJ1670 30-Jun-03
RJ1674 30-Jun-03
RK0554 31-Aug-02
RK0555 31-Aug-02
RK0688 31-Aug-02
RK1675 31-Jul-03
RK1678 31-Jul-03
RK1679 31-Aug-03
RL0692 30-Sep-02
RL0693 30-Sep-02
RL0694 30-Sep-02
RL0695 31-Oct-02
RL1977 31-Aug-03
RN0696 31-Oct-02
RN0701 31-Oct-02
RP0833 31-Oct-02
RP0836 30-Nov-03
RP0837 30-Nov-03
RP0838 31-Jan-03
RS0839 31-Jan-03
RS0841 31-Jan-03
RS0841 31-Jan-03
RS0842 31-Jan-03
RS0843 31-Jan-03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma USPD, Baltimore, MD, by letter on February 26, 2002.

Manufacturer: Armstrong Laboratories, Inc., West Roxbury, MA.
Firm initiated recall is ongoing.

REASON
Failure to test Purified Water ingredient for all microbial
specifications.

VOLUME OF PRODUCT IN COMMERCE
4,333,356 units.

DISTRIBUTION
Nationwide
.

 
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During 2000 there were over
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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.