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SafetyAlerts
December 12, 2001

Wyeth Ayerst ESI Lederle Has Recalled Meperidine HCL Injection

Cherry Hill, NJ  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Wyeth Ayerst ESI Lederle has recalled Meperidine HCL Injection.

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

PRODUCT
Meperidine HCL Injection, USP, 25,50,75 and 100 mg/mL-1 mL Dosette vials. Wyeth Ayerst, ESI Lederle,
Recall # D-042-2;
Recall # D-043-2;
Recall # D-044-2;
Recall # D-045-2.

Labeled Products:
Meperidine HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial.
Labeled Products:
Meperidine HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial.

CODES:
All lots (Baxter, ESI Lederle labels) within expiry of Mepridine HCL Injection, 25mg/ml, 50mg/ml, 75mg/ml, 100mg/ml.

ESI Lots:
25 mg/mL:
Lot 010095 EXP 10/01;
Lot 010127 EXP 10/01;
Lot 030093 EXP 12/01;
Lot 030097 EXP 12/01;
Lot 040048 EXP 1/02;
Lot 110135 EXP 8/02;
Lot 021175 EXP 11/02;
Lot 041010 EXP 1/03;
Lot 051087 EXP 2/03;
Lot 081004 EXP 5/03;
Lot 071173 EXP 4/03;
Lot 040106 EXP 1/02;
Lot 110065 EXP 8/02;
Lot 071125 EXP 4/03;
Lot 060032 EXP 3/02;
Lot 010151 EXP 10/01.
50 mg/mL:
Lot 010053 EXP 10/01;
Lot 010061 EXP 10/02;
Lot 020119 EXP 11/01;
Lot 030090 EXP 12/01;
Lot 030099 EXP 12/01;
Lot 030185 EXP 12/01;
Lot 030083 EXP 12/01;
Lot 050148 EXP 2/02;
Lot 050112 EXP 2/02;
Lot 040050 EXP 1/02;
Lot 040035 EXP 1/02;
Lot 070072 EXP 4/02;
Lot 110110 EXP 8/02;
Lot 120066 EXP 9/02;
Lot 050142 EXP 2/02;
Lot 021073 EXP 11/02;
Lot 031112 EXP12/02;
Lot 051089 EXP 2/03;
Lot 041167 EXP 1/03;
Lot 041131 EXP 1/03.
75 mg/mL:
Lot 031087 EXP 9/02;
Lot 050014 EXP 11/01;
Lot 050017 EXP 11/01;
Lot 090093 EXP 3/02;
Lot 061009 EXP 12/02;
Lot 071160 EXP 1/03.
100 mg/mL:
Lot 051074 EXP 11/02;
Lot 040149 EXP 10/01;
Lot 060136 EXP 12/02;
Lot 100061 EXP 4/02;
Lot 100063 EXP 4/02;
Lot 110004 EXP 5/02;
Lot 021080 EXP 8/02;
Lot 051018 EXP 11/02;
Lot 081137 EXP 2/03.
Baxter Lots:
25 mg/mL:
Lot 040103 EXP 1/02;
Lot 060038 EXP 3/02;
Lot 080115 EXP 5/02;
Lot 031114 EXP 12/02;
Lot 081167 EXP 5/03.
50 mg/mL:
Lot 020116 EXP 11/01;
Lot 030088 EXP 12/01;
Lot 040159 EXP 1/02;
Lot 060085 EXP 3/02;
Lot 060040 EXP 3/02;
Lot 060087 EXP 3/02;
Lot 070125 EXP 4/02;
Lot 080075 EXP 5/02;
Lot 080137 EXP 5/02;
Lot 090147 EXP 6/02;
Lot 090057 EXP 6/02;
Lot 110107 EXP 8/02;
Lot 011064 EXP 10/02;
Lot 021078 EXP11/02;
Lot 031079 EXP 12/02;
Lot 051076 EXP 2/03;
Lot 041002 EXP 1/03;
Lot 041014 EXP 1/03;
Lot 051132 EXP 2/03.
75 mg/Ml
Lot 080077 EXP 2/02;
Lot 031093 EXP 9/02.
100 mg/mL:
Lot 080182 EXP 2/02.

RECALLING FIRM/MANUFACTURER
Wyeth Ayerst ESI Lederle, Cherry Hill, NJ, by letter on 10/15/2001. Firm initiated recall ongoing.

REASON
Particulates (clear crystals).

VOLUME OF PRODUCT IN COMMERCE
581,240 packs.

DISTRIBUTION
Nationwide
.

 
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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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