Chart: FDA Recalls & Court Actions: May 29, 2002

FDA Recalls & Court Actions

May 29, 2002

CLASS II
Maxair Inhaler With Oral Adapter
Pirbuterol acetate, 0.2 mg per actuation, 25.6 g Inhalation Aerosol, 300 metered inhalations, Rx only. Lot numbers/Exp.: 000644, August '03; 000756, August '03; 000947, October '03; 001009, Nov. '03; 001110, Dec. '03; 001111, Dec. '03; 010025, Jan. '04; 010195, March '04; 010413, April '04; 010283, March '04; 010482, May '04; 010580, June '04; 010708, July '04; 010709, July '04; 010414, May '04; 011210, Dec. '04.
Manufacturer:	3M Pharmaceuticals, Inc., Northridge, CA.
Recalled by:	3M Pharmaceuticals, Inc., St. Paul, MN, by letters dated May 6, 2002. Firm initiated recall is ongoing.
Distribution:	Nationwide; 737,975 inhalers.
Reason:	Defective container; inhaler may stick intermittantly and patients may not receive the expected puff of medication.
Recall number:	D-264-2.
Various Injection Products by Pharmacia
(a) Adriamycin PFS, (doxorubicin hydrochloride) Injection USP, 150 mg/75 mL (2 mg/mL), 75 mL Multidose Cytosafe Vial, Rx only; (b) Adriamycin PFS, (doxorubicin hydrochloride) Injection, USP, 20 mg/10 mL (2 mg/mL), 10 mL Single dose Cytosafe Vial; (c) Adriamycin PFS, (doxorubicin hydrochloride) Injection USP, 200 mg/100 mL (2 mg/mL), 100 mL Multidose Cytosafe Vial, Rx only; (d) Ellence, (epirubicin hydrochloride) Injection, 200 mg/100 mL (2 mg/mL), Single use 100 mL Vial, Rx only; (e) Ellence, (epirubicin hydrochloride) Injection, 50 mg/25 mL (2 mg/mL), Single use 25 mL Vial, Rx only; (f) Idamycin PFS, (idarubicin hydrochloride) Injection, 10 mg/10 mL (1 mg/mL), 10 mL Single dose Cytosafe Vial, Rx only; (g) Idamycin PFS, (idarubicin hydrochloride) Injection, 20 mg/20 mL (1 mg/mL), 20 mL Single dose Cytosafe Vial, Rx only; (h) Idamycin PFS, (idarubicin hydrochloride) Injection, 5 mg/5 mL (1 mg/mL), 5 mL Single dose Cytosafe Vial, Rx only. Code (a) Lot R945, Exp. 02/03; lot R944, Exp. 02/03; lots R871 and R910, Exp. 02/03 and 02/03. (b) Lot R870, Exp. 03/03; lot T079, Exp. 04/03; (c) Lot R993, Exp. 03/03; lot T021, Exp. 03/03; lot T060, Exp. 03/03.
Manufacturer:	Pharmacia (Perth) Pty Limited, Bentley, WA, 6102, Australia.
Recalled by:	Pharmacia Corp., Kalamazoo, MI, by letter on May 10, 2002. Firm initiated recall is ongoing.
Distribution:	United States and Puerto Rico; 57,580 units.
Reason:	Lack of assurance of sterility.
Recall numbers:	D-268/275-2.

CLASS III
Claforan Sterile
Cefotaxime, for injection, USP. (a) Formerly sterile cefotaxime sodium, 500 mg IM/IV, Vial, Rx only; (b) Formerly sterile cefotaxime sodium, 1 gram IM/IV, Vial, Rx only; (c) Formerly sterile cefotaxime sodium, 2 grams IM/IV, Vial, Rx only. Lot No./Exp.: (a) 500-mg. x 10, 100632 Oct-02; 120416 Dec-02; 120469 Dec-02; 021969 Feb-03; 051739 May-03; 091877 Sep-03. (b) 1-gram x 50, 090668 Sep-02; 090686 Sep-02; 090688 Sep-02; 110558 Nov-02; 110565 Nov-02; 110567 Nov-02; 120421 Dec-02; 120452 Dec-02; 021912 Feb-03; 021910 Feb-03; 021914 Feb-03; 021913 Feb-03; 021911 Feb-03; 031902 Mar-03; 031903 Mar-03; 041786 Apr-03; 041829 Apr-03; 041858 Apr-03; 061704 Jun-03; 091881 Sep-03. (c) 2-gram x 10, 090683 Sep-02; 110551 Nov-02; 041729 Apr-03; 071840 Jul-03; 101894 Oct-03. 2-gram x 25, 110627 Nov-02; 031947 Mar-03; 041778 Apr-03; 071839 Jul-03. 2-gram x 50, 090679 Sep-02; 110554 Nov-02; 021948 Feb-03; 041730 Apr-03; 041791 Apr-03; 041821 Apr-03; 071838 Jul-03.
Manufacturer:	Patheon UK Limited, Swindon, Wiltshire SN35BZ, England.
Recalled by:	Aventis Pharmaceuticals, Inc., Kansas City, MO, by letter dated Feb. 22, 2002. Firm initiated recall is ongoing.
Distribution:	Nationwide; (a) 500-mg. - 418,200 vials; (b) 1-gram - 1,635,450 vials; (c) 2-gm. - 647,574 vials.
Reason:	Labeling; product label declares inactive ingredients that are not contained in the product (Dextrose Hydrous, USP, Sodium Citrate Hydrous, USP and Hydrochloric Acid)
Recall numbers:	D-265/267-2.
Ortho Micronor Oral Contraceptive Tablets
Norethindrone, 0.35 mg, 28 tablets in a ring-shaped blister pack, Rx only. Trade: NDC 0062-1411-16 - Lot 11M001, Exp. 11/04; Lot 11M002 Exp. 11/04; Lot 12C003, Exp. 01/05; Lot 12C004, Exp. 02/05. Physician Samples: NDC 0062-1411-29, Lot 11M019, Exp. 11/04; refills: NDC 0062-1411-23, Veridate 12A029, Exp. 01/05; 12C030, Exp. 01/05.
Manufacturer:	Ortho-Mcneil Pharmaceutical Inc., Manati, Puerto Rico
Recalled by:	Ortho-Mcneil Pharmaceutical, Inc., Raritan, NJ, by letters on April 3, 2002. Firm initiated recall is ongoing.
Distribution:	Nationwide; Trade -- 339,336 blisters; Veridate -- 40,320 blisters; Samples -- 124,704.
Reason:	Mislabeling; labeling incorrectly informs user that missing any pills 22- 28 will still leave them protected.
Recall number:	D-280-2.
Q-Bid DM Sustained Release Tablet
Guaifenesin 600 mg/Dextromethorphan 30 mg, 100 tablet bottles, Rx only. Lot No. 005F1F.
Manufacturer:	Vintage Pharmaceuticals, Inc., Huntsville, AL.
Recalled by:	Manufacturer, by letter on Feb. 21, 2002. Firm initiated recall is ongoing.
Distribution:	Nationwide; 14,150 bottles of 100 tablets.
Reason:	Tablet mix-up; Q-Bid LA tablet containing the active ingredient guaifenesin was found in a bottle of Q-Bid DM.
Recall number:	D-279-2.
Various Ointment and Gel Products by Carlstadt
(a) Ziox Ointment (papain-urea-chlorophyllin copper complex sodium) 30 gram tube, Rx only; (b) Kovia Ointment (papain-urea), 30 gram tube, Rx only; (c) Nuquin HP 4% Gel (hydroquinone USP, 4%), 1/2 oz. and 1 oz. tubes, Rx only. Code (a) Lot No. 5075 Exp. 6/2003; (b) Lot No. 5041 Exp. 6/2002; (c) Lot No. 5015 Exp. 9/2002.
Manufacturer:	Sonar Products Inc., Carlstadt, NJ.
Recalled by:	Manufacturer, by letter on March 6, 2002. Firm initiated recall is complete.
Distribution:	FL; (a) 9,648 x 30 g tubes; (b) 51,201 x 30 g tubes; (c) 4,731 x 30 g tubes, 2,537 x 15 g tubes.
Reason:	Subpotent: (a) Ziox and (b) Kovia Ointment for papain and (c) Nuquin 4% for padimate-o and dioxybenzone.
Recall numbers:	D-276/278-2.