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SafetyAlerts
April 9, 2003

Lee Pharmacy Has Recalled Various Injections

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Betamethasone Injection Repository P.F. 6mg,
Preservative Free, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-201-3;
b) Betamethasone Sodium Phosphate Injection, Preservative
Free, 12mg/mL, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-202-3;
c) Bupivacaine 0.25% Injection, Preservative Free, Single
Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-203-3;
d) Clonidine Hydrochloride Injection, 100mg, Preservative
Free, Single Dose Vial, Lee Pharmacy, Inc., 4300 Grand
Avenue, Fort Smith, AR 72904, sold in 1ml, 2 ml, 5ml, or
10ml vials. Recall # D-204-3.
e) Co-Enzyme Q-10 Injection, Preservative Free, Single Dose
Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-205-3;
f) EDTA 150 mg/ml injection, 100 ml, Preservative Free.
Recall # D-206-3;
g) Hyaluronidase 150U/ml injection, Preservative Free,
Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-207-3.
h) Sodium Chloride 23.4% Injection, Preservative Free,
Single Dose, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-208-3;
i) Sodium Chloride 10% Injection, Preservative Free, Single
Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-209-3;
j) Sodium Chloride 3% Injection, Preservative Free,
Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall #B-210-3.
k) Triamcinolone Acetonide Injection, 40mg/ml P.F.,
Preservative Free, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-211-3;
l) Triamcinolone Diacetate,40 mg/ml P.F., Preservative
Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml
Vials. Recall # D-212-3;
m) Betamethasone LA-SA, Injection, 12mg/ml, Preservative
Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml
Vials. Recall # D-213-3.

CODE
a) 19022002:71; 20022002:02; 02042002:65; 14052002:50;
21052002:19; 10062002:14; 09072002:20; 29072002:12;
30072002:22; 20082002:27; 09092002:81; 4642:76; 4678:46;
4706:40; 4755:77; 4786:27; 4831:25; 4850:25;
11032002:24; 4848:35; 02072002:23;
b) 13062002:46; 27082002:15; 4722:37; 4702:55; and 4721:33;
c) 23012002:98 02042002:40 12062002:79 22082002:45 4742:96;
d) 14082002:42 20092002:39 4663:40;
e) 15022002:08;
f) 21082002:24 4645:62 4761:84;
g) 22082002:88 16092002:28;
h) 4746:25;
i) 4714:50;
j) 4690:43;
k) 20062002 25042002:64 03062002:38 02072002:58 02082002:31
27082002:21 09092002:88 4737:75;
l) 05022002:48 11022002:43 11032002:55 21032002:41
15042002:44 25042002:54 20052002:71 29052002:19
30052002:54;
m) 14052002:65.

RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR, by letters dated December 24, 2002 and December 30, 2002. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
Unknown

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.