WEEK ENDING JUNE 2
PRODUCT Afassco brand Alcohol Prep Pad, 70% Isopropyl
Alcohol USP, antiseptic wipes, 24 swabs and 100 swabs per box.
CODE Order #626 and 2626, All lot codes.
MANFACTURER Afassco, Carson City, Nevada.
COMPONENT MANFACTURER Clinipad Corporation, Charlotte,
North Carolina.
DISTRIBUTION Nationwide.
QUANTITY 282,528 units were distributed.
REASON Lack of assurance of sterility on product received
from Clinipad Corporation.
PRODUCT a) Albuterol, USP inhalation Aerosol,17
g, 200 metered inhalations: Proventil Aerosol Inhaler 90MCG Per Actuation
17G Canister, NDC 0885-0614-02; Proventil Inhalation Aerosol (Refill) 90
MCG 17G Canister NDC 0885-0614-03; Albuterol USP Inhalation Aerosol 90MCG
17G Canister Warrick NDC 9930-1560-01; Albuterol USP Inhalation Aerosol
90MCG 17G Canister Refill Warrick NDC 9930-1560-02. Private Labels: Martec
NDC 5255-5594-17, 5255-5594-18 (refill); Major NDC 0904-5078-34 and NDC
0904-5078-68 (refill); Qualitest NDC 0603-1004-75; Novopharm NDC 5595-3051-53
and 5595-3501-01 (refill); Schein NDC 0364-2632-98; United Research Laboratory
NDC #0671-1549-70.
b) Vanceril Double Strength Inhalation Aerosol (beclomethasone
dipropionate), 84 mcg, 40 (5.4 g) and 120 (12.2g) metered inhalations,
Rx for maintenance treatment of asthama. (NDC 0085-1112-01 and NDC 0085-1112-03)
c) Vanceril Inhalation Aerosol (beclomethasone dipropionate),
42 mcg, 80 (6.7 g) and 200 (16.8g) metered inhalations, Rx, for maintenance
treatment of asthma (NDC #0085-0736-04 and 0085-0738-12)
d) Vancenase POCKETHALER® Nasal Aerosol, (beclomethasone
dipropionate), 42 mcg, 200 (7g) metered doses, Rx indicated for the relief
of the symptoms of seasonal or perennia rhinitis. (NDC #0085-0649-02)
e) Vancenase Nasal Aerosol, (beclomethasone dipropionate),
42 mcg, 200 (16.8g) metered doses, Rx indicated for the relief of the symptoms
of seasonal or perennia rhinitis. (NDC #0085-0041-16)
CODE PROVENTIL/ALBUTEROL INHALERS
BATCH EXPIRATION DATE
7-BBS-303 03/31/00 7-BBS-600 03/31/00 7-BBS-601 03/31/00
7-BBS-602 03/31/00 7-BBS-603 03/31/00 7-BBS-604 03/31/00
7-BBS-605 03/31/00 7-BBS-606 03/31/00 7-BBS-607 03/31/00
7-BBS-608 03/31/00 7-BBS-609 03/31/00 7-BBS-610 03/31/00
7-BBS-611 03/31/00 7-BBS-612 04/30/00 7-BBS-613 04/30/00
7-BBS-614 04/30/00 7-BBS-617 04/30/00 7-BBS-618 04/30/00
7-BBS-619 04/30/00 7-BBS-620 04/30/00 7-BBS-621 04/30/00
7-BBS-622 04/30/00 7-BBS-623 05/31/00 7-BBS-624 05/31/00
7-BBS-625 05/31/00 7-BBS-626 05/31/00 7-BBS-627 05/31/00
7-BBS-628 05/31/00 7-BBS-629 05/31/00 7-BBS-630 05/31/00
7-BBS-631 05/31/00 7-BBS-632 05/31/00 7-BBS-633 06/30/00
7-BBS-634 06/30/00 7-BBS-635 06/30/00 7-BBS-636 06/30/00
7-BBS-637 06/30/00 7-BBS-638 06/30/00 7-BBS-639 06/30/00
7-BBS-640 06/30/00 7-BBS-641 06/30/00 7-BBS-642 06/30/00
8-BBS-500 07/31/00 8-BBS-501 07/31/00 8-BBS-502 07/31/00
8-BBS-503 07/31/00 8-BBS-505 07/31/00 8-BBS-506 07/31/00
8-BBS-507 07/31/00 8-BBS-508 07/31/00 8-BBS-509 07/31/00
8-BBS-510 07/31/00 8-BBS-511 08/31/00 8-BBS-512 08/31/00
8-BBS-613 08/31/00 8-BBS-514 08/31/00 8-BBS-515 08/31/00
8-BBS-516 08/31/00 8-BBS-517 08/31/00 8-BBS-518 08/31/00
8-BBS-519 08/31/00 8-BBS-520 08/31/00 8-BBS-521 08/31/00
8-BBS-522 08/31/00 8-BBS-523 08/31/00 8-BBS-524 08/31/00
8-BBS-526 09/30/00 8-BBS-527 09/30/00 8-BBS-528 09/30/00
8-BBS-529 09/30/00 8-BBS-530 09/30/00 8-BBS-531 09/30/00
8-BBS-532 09/30/00 8-BBS-533 09/30/00 8-BBS-534 09/30/00
8-BBS-535 09/30/00 8-BBS-536 09/30/00 8-BBS-537 09/30/00
8-BBS-538 09/30/00 8-BBS-539 09/30/00 8-BBS-540 09/30/00
8-BBS-541 09/30/00 8-BBS-542 10/31/00 8-BBS-543 10/31/00
8-BBS-544 10/31/00 8-BBS-545 10/31/00 8-BBS-546 10/31/00
8-BBS-547 10/31/00 8-BBS-548 10/31/00 8-BBS-549 10/31/00
8-BBS-550 10/31/00 8-BBS-551 10/31/00 8-BBS-552 10/31/00
8-BBS-553 10/31/00 8-BBS-555 11/30/00 8-BBS-556 11/30/00
8-BBS-557 11/30/00 8-BBS-559 11/30/00 8-BBS-560 11/30/00
8-BBS-561 11/30/00 8-BBS-562 11/30/00 8-BBS-563 11/30/00
8-BBS-564 11/30/00 8-BBS-565 11/30/00 8-BBS-566 12/31/00
8-BBS-567 12/31/00 8-BBS-568 12/31/00 8-BBS-569 12/31/00
8-BBS-570 12/31/00 8-BBS-571 12/31/00 8-BBS-572 12/31/00
8-BBS-573 12/31/00 8-BBS-574 12/31/00 8-BBS-575 12/31/00
8-BBS-576 12/31/00 8-BBS-577 12/31/00 8-BBS-578 12/31/00
8-BBS-579 01/31/01 8-BBS-580 01/31/01 8-BBS-581 01/31/01
8-BBS-582 01/31/01 8-BBS-583 01/31/01 8-BBS-584 01/31/01
8-BBS-585 01/31/01 8-BBS-586 01/31/01 8-BBS-587 01/31/01
8-BBS-588 01/31/01 8-BBS-589 02/28/01 8-BBS-590 02/28/01
8-BBS-591 02/28/01 8-BBS-592 02/28/01 8-BBS-593 02/28/01
8-BBS-594 02/28/01 8-BBS-595 02/28/01 8-BBS-596 02/28/01
8-BBS-597 02/28/01 8-BBS-598 02/28/01 8-BBS-599 03/31/01
8-BBS-600 03/31/01 8-BBS-601 03/31/01 8-BBS-602 03/31/01
8-BBS-603 03/31/01 8-BBS-604 03/31/01 8-BBS-605 03/31/01
8-BBS-606 03/31/01 8-BBS-607 10/31/00 8-BBS-609 04/30/01
8-BBS-610 04/30/01 8-BBS-611 04/30/01 8-BBS-612 04/30/01
8-BBS-613 04/30/01 8-BBS-614 04/30/01 8-BBS-615 04/30/01
8-BBS-620 05/31/01 8-BBS-621 05/31/01 8-BBS-622 05/31/01
8-BBS-635 06/30/01 8-BBS-636 06/30/01 8-BBS-638 06/30/01
8-BBS-639 06/30/01 8-BBS-640 06/30/01 8-BBS-641 06/30/01
8-BBS-642 06/30/01 8-BBS-643 06/30/01 8-BBS-644 06/30/01
8-BBS-645 07/31/01 8-BBS-646 07/31/01 8-BBS-800 10/31/00
8-BBS-801 10/31/00 8-BBS-802 10/31/00 8-BBS-803 10/31/00
8-BBS-804 10/31/00 8-BBS-805 11/30/00 8-BBS-806 11/30/00
8-BBS-807 11/30/00 8-BBS-808 11/30/00 8-BBS-809 12/31/00
8-BBS-810 01/31/01 8-BBS-811 01/31/01 8-BBS-812 01/31/01
8-BBS-813 01/31/01 8-BBS-814 02/28/01 8-BBS-815 02/28/01
8-BBS-816 02/28/01 8-BBS-817 02/28/01 8-BBS-818 03/31/01
8-BBS-819 03/31/01 8-BBS-820 03/31/01 8-BBS-821 03/31/01
8-BBS-822 06/30/01 8-BBS-823 06/30/01 8-BBS-824 06/30/01
8-BBS-825 06/30/01 8-BBS-826 07/31/01 9-BBS-500 07/31/01
9-BBS-501 07/31/01 9-BBS-502 07/31/01 9-BBS-503 07/31/01
9-BBS-504 07/31/01 9-BBS-505 07/31/01 9-BBS-506 07/31/01
9-BBS-507 07/31/01 9-BBS-508 07/31/01 9-BBS-509 07/31/01
9-BBS-510 07/31/01 9-BBS-511 08/31/01 9-BBS-512 08/31/01
9-BBS-513 08/31/01 9-BBS-514 08/31/01 9-BBS-515 08/31/01
9-BBS-516 08/31/01 9-BBS-517 08/31/01 9-BBS-518 08/31/01
9-BBS-519 08/31/01 9-BBS-520 08/31/01 9-BBS-521 08/31/01
9-BBS-522 08/31/01 9-BBS-523 08/31/01 9-BBS-524 08/31/01
9-BBS-525 08/31/01 9-BBS-529 09/30/01 9-BBS-530 09/30/01
9-BBS-531 09/30/01 9-BBS-532 09/30/01 9-BBS-533 09/30/01
9-BBS-534 09/30/01 9-BBS-535 09/30/01 9-BBS-536 09/30/01
9-BBS-537 09/30/01 9-BBS-538 09/30/01 9-BBS-539 09/30/01
9-BBS-540 03/31/01 9-BBS-541 09/30/01 9-BBS-542 03/31/01
9-BBS-543 04/30/01 9-BBS-544 04/30/01 9-BBS-545 04/30/01
9-BBS-546 04/30/01 9-BBS-547 04/30/01 9-BBS-548 04/30/01
9-BBS-549 04/30/01 9-BBS-550 04/30/01 9-BBS-551 04/30/01
9-BBS-552 04/30/01 9-BBS-553 04/30/01 9-BBS-554 04/30/01
9-BBS-555 04/30/01 9-BBS-556 04/30/01 9-BBS-557 05/31/01
9-BBS-558 05/31/01 9-BBS-559 05/31/01 9-BBS-560 05/31/01
9-BBS-561 05/31/01 9-BBS-562 05/31/01 9-BBS-563 05/31/01
9-BBS-564 05/31/01 9-BBS-565 05/31/01 9-BBS-566 05/31/01
9-BBS-567 05/31/01 9-BBS-568 05/31/01 9-BBS-569 05/31/01
9-BBS-570 05/31/01 9-BBS-571 06/30/01 9-BBS-572 06/30/01
9-BBS-573 06/30/01 9-BBS-574 06/30/01 9-BBS-575 06/30/01
9-BBS-576 06/30/01 9-BBS-578 06/30/01 9-BBS-579 06/30/01
9-BBS-580 06/30/01 9-BBS-581 06/30/01 9-BBS-582 07/31/01
9-BBS-583 07/31/01 9-BBS-584 07/31/01 9-BBS-585 07/31/01
9-BBS-586 07/31/01 9-BBS-587 07/31/01 9-BBS-588 07/31/01
9-BBS-589 07/31/01 9-BBS-590 07/31/01 9-BBS-591 07/31/01
9-BBS-592 07/31/01 9-BBS-593 07/31/01 9-BBS-594 08/31/01
9-BBS-595 08/31/01 9-BBS-596 08/31/01 9-BBS-597 08/31/01
9-BBS-598 08/31/01 9-BBS-599 08/31/01 9-BBS-600 08/31/01
9-BBS-601 08/31/01 9-BBS-602 08/31/01 9-BBS-603 08/31/01
9-BBS-604 08/31/01 9-BBS-605 08/31/01 9-BBS-606 08/31/01
9-BBS-607 08/31/01 9-BBS-608 08/31/01 9-BBS-609 08/31/01
9-BBS-610 09/30/01 9-BBS-611 09/30/01 9-BBS-612 09/30/01
9-BBS-613 09/30/01 9-BBS-614 09/30/01 9-BBS-615 09/30/01
9-BBS-616 09/30/01 9-BBS-617 09/30/01 9-BBS-618 09/30/01
9-BBS-619 09/30/01 9-BBS-620 09/30/01 9-BBS-621 09/30/01
9-BBS-622 09/30/01 9-BBS-623 09/30/01 9-BBS-800 07/31/01
9-BBS-801 07/31/01 9-BBS-802 07/31/01 9-BBS-803 07/31/01
9-BBS-804 07/31/01 9-BBS-805 07/31/01 9-BBS-806 07/31/01
9-BBS-807 07/31/01 9-BBS-808 08/31/01 9-BBS-809 08/31/01
9-BBS-810 08/31/01 9-BBS-811 02/28/01 9-BBS-815 03/31/01
9-BBS-816 04/30/01 9-BBS-817 04/30/01 9-BBS-818 04/30/01
9-BBS-819 04/30/01 9-BBS-820 04/30/01 9-BBS-821 07/31/01
9-BBS-822 07/31/01 9-BBS-823 07/31/01 9-BBS-824 07/31/01
9-BBS-825 07/31/01 9-BBS-826 07/31/01 9-BBS-827 08/31/01
9-BBS-828 08/31/01 9-BBS-829 08/31/01 9-BBS-830 08/31/01
9-BBS-831 08/31/01 9-BBS-832 08/31/01.
VANCERIL INHALER (AMA) -- BATCH EXPIRATION DATE
8-AMA-208.03/31/00 8-AMA-209.03/31/00 8-AMA-210.03/31/00
8-AMA-211.03/31/00 8-AMA-212.09/30/00 8-AMA-213.09/30/00
8-AMA-214.09/30/00 8-AMA-215.10/31/00 8-AMA-216.10/31/00
8-AMA-217.10/31/00 8-AMA-219.11/30/00 8-AMA-220.11/30/00
8-AMA-221.11/30/00 8-AMA-222.11/30/00 8-AMA-408.04/30/00
8-AMA-409.04/30/00 8-AMA-410.04/30/00 8-AMA-600.09/30/00
8-AMA-701.06/30/00 8-AMA-702.06/30/00 8-AMA-703.09/30/00
9-AMA-200.02/28/01 9-AMA-201.02/28/01 9-AMA-202.02/28/01
9-AMA-203.02/28/01 9-AMA-204.03/31/01 9-AMA-205.03/31/01
9-AMA-206.03/31/01 9-AMA-207.03/31/01 9-AMA-208.04/30/01
9-AMA-209.04/30/01 9-AMA-210.04/30/01 9-AMA-211.04/30/01
9-AMA-212.04/30/01 9-AMA-213.05/31/01 9-AMA-214.05/31/01
9-AMA-215.05/31/01 9-AMA-216.05/31/01 9-AMA-217.07/31/01
9-AMA-218.07/31/01 9-AMA-219.07/31/01 9-AMA-220.07/31/01
9-AMA-221.07/31/01 9-AMA-222.07/31/01 9-AMA-223.09/30/01
9-AMA-225.09/30/01 9-AMA-226.09/30/01 9-AMA-227.09/30/01
9-AMA-228.09/30/01 9-AMA-401.02/28/01 9-AMA-402.02/28/01
9-AMA-403.03/31/01 9-AMA-404.03/31/01
VANCERIL DOUBLE STRENGTH INHALER BATCH
EXPIRATION DATE
8-DMT-644 03/31/00 8-DMT-646 03/31/00 9-DMT-133 03/31/00
9-DMT-134 03/31/00 9-DMT-135 03/31/00 9-DMT-136 03/31/00
9-DMT-137 03/31/00 9-DMT-139 05/31/00 9-DMT-140 05/31/00
9-DMT-141 05/31/00 9-DMT-142 05/31/00 9-DMT-143 05/31/00
9-DMT-144 05/31/00 9-DMT-145 05/31/00 9-DMT-146 05/31/00
9-DMT-147 05/31/00 9-DMT-148 05/31/00 9-DMT-149 05/31/00
9-DMT-150 05/31/00 9-DMT-151 05/31/00 9-DMT-152 05/31/00
9-DMT-153 05/31/00 9-DMT-154 05/31/00 9-DMT-155 05/31/00
9-DMT-156 05/31/00 9-DMT-157 07/31/00 9-DMT-158 07/31/00
9-DMT-160 07/31/00 9-DMT-161 07/31/00 9-DMT-163 07/31/00
9-DMT-600 07/31/00 9-DMT-601 07/31/00 9-DMT-608 08/31/00
9-DMT-610...10/31/00 9-DMT-616 11/30/00 9-DMT-617 11/30/00
9-DMT-618 11/30/00 9-DMT-619 11/30/00 9-DMT-620 11/30/00
9-DMT-621 11/30/00
VANCENASE POCKETHALER (RRG) BATCH EXPIRATION
DATE
8-RRG-113...04/30/00 8-RRG-114...04/30/00
8-RRG-115...04/30/00 8-RRG-116...04/30/00
8-RRG-117...05/31/00 8-RRG-118.. 05/31/00
8-RRG-119...05/31/00 8-RRG-120...05/31/00
8-RRG-121...05/31/00 9-RRG-101 09/30/00
9-RRG-103...09/30/00 9-RRG-104 09/30/00
9-RRG-107 11/30/00
9-RRG-109...11/30/00 9-RRG-110...11/30/00
9-RRG-111... 12/31/00 9-RRG-112...12/31/00
9-RRG-113...12/31/00
9-RRG-114... 03/31/01 9-RRG-116...03/31/01
9-RRG-117...03/31/01 9-RRG-118... 03/31/01
9-RRG-119...03/31/01
VANCENASE NASAL INHALER (AMA) BATCHEXPIRATION
DATE
8-AMA-600 09/30/00 9-AMA-100.02/28/01.
MANFACTURER Schering Laboratories, Kenilworth, New Jersey.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY Proventil/Albuterol inhalers: 58,936,179 units
Vanceril 84 mcg: 831,594 units
Vanceril 42 mcg: 5,274,819 units Vancenase: 2,706,425
units were distributed.
REASON Some canisters may not have active ingredient.
PRODUCT Vira-A(r) Ophthalmic Ointment, USP 3%,
(Vidarabine), in 3.5 gram tubes, Rx. NDC #61570-367-71 (1 tube carton)
and NDC 61570-367-72 (12 tube carton).
CODE Lot #5739 EXP 01/02.
MANFACTURER Parkedale Pharmaceuticals, Inc., A wholly
owned subsidiary of King Pharmaceuticals, Rochester, Michigan.
RECALLED BY King Pharmaceuticals, Inc., Bristol, Tennessee
DISTRIBUTION Nationwide.
QUANTITY 38,704 tubes were distributed.
REASON Leaking tubes at crimp end.
PRODUCT Caverject(r) Injection, Rx for intravernosal
use only:
a) Caverject(r) Injection (alprostadil 20mcg), NDC #0009-3701-01
b) Caverject(r) Injection (alprostadil 10mcg), NDC #0009-3778-08
c) Caverject(r) Injection (alprostadil 5mcg), NDC #0009-7212-03
d) Companion pack for Caverject(r) Injection (alprostadil),
Rx contains 5 companion packs. Each companion pack contains 2 sterile needles,
1-2 ml sterile syringe assembly and 1 alcohol swab.
CODE All lot numbers.
MANFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan.
Anajay, Inc., Charlotte (name on alcohol swabs).
RECALLED BY Pharmacia & Upjohn, Kalamazoo, Michigan
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Lack of assurance of sterility with alcohol preps
manufactured by the Clinipad Company, packaged with Caverject(r) product.
PRODUCT Solu-Medrol Methylprednisolone Sodium Succinate
for Injection, USP, 125 mg, Act-O-Vial(r) single dose vial, 2mL, Rx sterile
powder.
CODE Lot #50DHD EXP 7/31/02.
MANFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan.
DISTRIBUTION Nationwide.
QUANTITY 5,252 cartons of 25 vials each were distributed.
REASON Lack of assurance of sterility.
PRODUCT Methadose(r) (Methadone Hydrochloride Oral
Concentrate, USP), 10mg/mL, in 1 quart bottles, Rx for detoxification and
maintenance treatment for narcotic addiction. NDC#0406-0527-05.
CODE Lot #B01461 EXP 02/01.
MANFACTURER Mallinckrodt, Inc., St. Louis, Missouri.
DISTRIBUTION Nationwide.
QUANTITY 1,060 bottles were distributed.
REASON Superpotency.
PRODUCT a) Zilatone Laxative Tablets, (Phenolphthalein
32 mg per tablet), OTC in 50 tablet bottles; b) Zilatone Laxative Digestive
Aid Tablets, Phenolphthalein 32 mg per tablet), OTC in 50 tablet bottles.
CODE a) All lots with expiration dates from EXP OCT 01
to EXP JUN 02; b) All lots with expiration dates prior to EXP OCT 01.
MANFACTURER Abco Laboratories, Inc., Fairfield, California.
RECALLED BY The Heritage Store, Inc., Virginia Beach,
Virginia
DISTRIBUTION Nationwide.
QUANTITY 1,227 units were distributed; firm estimated
that 20 units remained on market at time of recall initiation.
REASON Products contain phenolphthalein which is not
generally recognized as safe and effective in over-the-counter stimulant
laxatives.
PRODUCT Prep-Clean Kits, containing sterile antiseptic
pads, used for cleaning and disinfecting cartridge type, full-face and
helmet respirators utilized by industry. Sterile prep pads included in
the kits are labeled as Clinipad Corporation, Charlotte, NC, coded NDC-19154-1245-8,
Reorder code 0250B, Lot 819178.
CODE Kit Numbers: PC333, PC444, PC555, PC777.
MANFACTURER Georgia Steel and Chemical Company, Annapolis
Junction, Maryland.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Maryland, Pennsylvania, Wisconsin, Kentucky,
Texas, Louisiana, Indiana, Tennessee, Florida, Missouri, Colorado.
QUANTITY 936 kits were distributed.
REASON Cleaning kits contain alcohol pads for which the
pad manufacturer (Clinipad Company)cannot assure sterility.
PRODUCT Oxygen, USP, Compressed, in size D cylinders.
CODE Lot #042105 EXP 4/21/05.
MANFACTURER Home Nursing Care, Inc., doing business as
Community Home Care Services, Richlands, Virginia.
DISTRIBUTION Virginia.
QUANTITY 2 cylinders were distributed.
REASON Current good manufacturing deviations including
but not limited to document pre-fill, fill and post fill operations.
PRODUCT VioNex Antimicrobial skin wipe towelette,
(0.5% Parachlorometaxylenol), OTC used to clean skin when soap and water
are not available. NDC #55443-0102-1.
CODE Lot Numbers: 903193, 911283, 912850, and 913598.
MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
RECALLED BY Sybron Dental Specialties, Inc., Orange,
California
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY 2,481.4 cases (10 units per case) of all lots
were distributed.
REASON Towelettes manufacturer (Clinipad Company) cannot
assure product meets microbial release specifications.
PRODUCT Promethazine Syrup Plain, 6.25 mg/5mL in
4 and 16 ounce bottles, Rx for the treatment of perennial and seasonal
allergic rhinitis, vasomotor rhinitis, allergic reaction, sedation in both
children and adults, and antiemetic therapy in posoperative patients, packaged
under the MGP (NDC #60432-608-16) and Major Pharmaceuticals (NDC#0904-1508-16)
labels.
CODE Lot Numbers: 22086A, 22086C, 22086E, 22148A, 22148C,
22148E, 22148F, 22148H, 22345A, 22345C, 22345E, 22345F, 22481A, 22481C,
22623A, 22623C, 22623E, 22623F, 22623H, 22806A, 22806C, 22806E, 22806F,
23020A, 23020C, 23020E, 23020F, 23020K .
MANFACTURER Morton Grove Pharmaceuticals, Morton Grove,
Illinois.
DISTRIBUTION Nationwide.
QUANTITY 7,224 4-ounce and 1,536 16-ounce bottles were
distributed.
REASON Subpotency (at stability testing).
PRODUCT Allegra-D Extended-Release Tablets, (Fexofenadine
HCL 60 mg and Pseudoephedrine HCL 120 mg), in 100 tablet bottles, Rx. DC
#0088-1090-47.
CODE Lot #1017145 EXP 6/01.
MANFACTURER Aventis Pharmaceuticals, Inc., Kansas City,
Missouri.
DISTRIBUTION Nationwide.
QUANTITY 12,556 bottles were distributed.
REASON Expiration date incorrectly declared (June 2001
instead May 2001).
PRODUCT Roberts Pharmaceuticals brand Entuss-D
liquid Antitussive, nasal decongestant, expectorant. 16 fl. Oz. Rx Control
Schedule III. Contains hydrocodone bitartrate 5 mg., pseudoephedrine hydrochloride
30 mg., potassium guaiacolsulfonate 300 mg per 5 ml.
CODE Lot M78280 EXP 12/00.
MANFACTURER Schwarz Pharma Manufacturing, Inc., Seymour,
Indiana.
DISTRIBUTION California and New Jersey.
QUANTITY 3,344 bottles were distributed.
REASON Subpotent (24 month stability).
PRODUCT NeGram Suspension (Nalidixic Acid Oral
Suspension, USP), 250 mg/5mL, in 1 pint bottles, Rx indicated for the treatment
of urinary tract infections. NDC #0024-1318-06.
MANFACTURER Bayer Corporation, Myerstown, Pennsylvania.
RECALLED BY Sanofi Pharmaceutical, Inc., New York
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,200 units were distributed; firm estimated
that 60 units remained on market at time of recall initiation.
REASON Superpotent (at stability - 12 months).
PRODUCT Zantac (Ranitidine Tablets), 75 mg, 4 tablet
units, OTC acid reducer. NDC #0501-5200-04.
CODE Lot #8ZP1066 EXP 06/01. UPC 3-12547-68404-0.
MANFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina.
RECALLED BY The Consumer Healthcare Division of Warner-Lambert
Company, Morris Plains, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 10,924 cases were distributed.
REASON Product fails appearance of specification due
to container/packaging deviation.
PRODUCT Promethazine with Codeine Cough Syrup,
6.25 mg/5mL and 10 mg/5mL, in 4-fluid ounce bottles, Rx for the temporary
relief of coughs and upper respiratory symptoms associated with allergy
or the common cold under the MGP label label NDC #60432-606-04.
CODE Lot #22649A.
MANFACTURER Morton Grove Pharmaceuticals, Morton Grove,
Illinois.
DISTRIBUTION Nationwide.
QUANTITY 4,128 bottles were distributed.
REASON Subpotency (at stability testing).
PRODUCT Cefuroxime for Injection USP, 7.5 mg, IM/IV
use, pharmacy bulk package for preparing IV admixtures, Rx. NDC #59772-6569-1.
CODE C2424 EXP 6/01, C2522 EXP 11/01, C2562 EXP 3/02.
MANFACTURER Bristol-Myers Squibb Company, Princeton,
New Jersey (own label distributor).
RECALLED BY G.C. Hanford Mfg. Company, Syracuse, New
York
DISTRIBUTION California, Florida, Illinois, Louisiana,
Massachusetts, Missouri, Minnesota, Mississippi, North Carolina, New Jersey,
New York, Pennsylvania, Tennessee, Texas, Utah, Washington state, Wisconsin,
West Virginia, international.
QUANTITY 9,150 vials of lot C2424 and 8,870 vials of
lot C2522 were distributed. None of lot C8760 left the control of Bristol-Myers
Squibb.
REASON Mislabeling - Back panel of carton incorrectly
declares 750 mg of Cefuroxime activity per mL instead of the correct per
8mL.
WEEK ENDING JUNE 16
PRODUCT Brethaire(r) Inhalation Aerosol (Terbutaline
sulfate,) 7.5 mL, Complete Unit, NDC #0028-5557-88, and 7.5 mL refill,
NDC #0028-5557-87, Rx inhaler for relief of reversible bronchospasm in
patients with obstructive airway disease such as asthma, bronchitis, and
emphysema.
CODE Lot numbers: 1971259, 2971259 and 4971259, 3971259
EXP 11/99.
MANUFACTURER 3M Pharmaceuticals, Northridge, California.
RECALLED BY Novartis Pharmaceuticals Corporation, Suffern,
New York
DISTRIBUTION Nationwide.
QUANTITY
9,210 - lot 1971259
23,904 - lot 2971259
26,982 - lot 4971259
11,982 - lot 3971259 lots were distributed. Firm estimates
none remain on market.
REASON Aerodynamic particle size failure (stability).
PRODUCT a) Acetone Alcohol in preps (CS-1000-VWR
Catalog #15649-000), Swabs (CS-500-VWR-15649-012);
b) Iodophor in swabs (PVP-50-VWR Catalog #15649-002 and
500 C/S Catalog #15649-018), pads (PVP Prep 200 pack VWR Catalog #15649-016);
c) Iodine Tinc. in Swabs (VWR Catalog #15649-006 and
010) and sol ptns 12x16 oz. Pack (VWR Catalog #15649-034);
d) Alcohol in swabs 25 pack (VWR Catalog #15649-008 and
LX15649-008) and prep pads Med NS 20 pack (VWR Catalog #15649-024) and
Towelette Clinipad (VWR Catalog #15649-014);
e) Povodone Iodine in Scrub/Gal 4 CS (VWR Catalog #15649-030)
and Gal (VWR #BA15649-030AB);
f) Benzalkonium Chloride 1/2-oz. (VWR Catalog #15649-028);
g) Green Soap Tinc. in swabs, 500/CS (VWR #15649-020).
CODE All lots.
MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
RECALLED BY VWR Scientific Products Corporation, West
Chester, Pennsylvania
DISTRIBUTION Alabama, California, Connecticut, Georgia,
Illinois, Indiana, Maryland, Michigan, North Carolina, New Jersey, Ohio,
Pennsylvania, Texas.
QUANTITY 133 units were distributed.
REASON Manufacturer (Clinipad Corporation) unable to
assure product meets release microbiological specifications.
PRODUCT Imitrex(r) (sumatriptan succinate) Rx tablets,
25 mg, in 9-tablet units. NDC #0173-0460-02
CODE Lot Numbers: OZP0151 and OZP0152.
MANUFACTURER Glaxo Wellcome, Zebulon, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY Approximately 12,157 units from lot OZP0151,
and 25,553 units from lot OZP0152 are in distribution channels.
REASON Misbranding - Blister text incorrectly declares
product strength at 50 mg (outer carton is correctly labeled (25 mg).
PRODUCT a) Doxycycline Hyclate Capsules, USP, 50
MG in bottles of 50, NDC 0364-2032-50, and bottles of 100 (10 X 10), NDC
0364-2033-90;
b) Doxycycline Hyclate Capsules, USP 100 MG in bottles
of 50, NDC 0364-2033-50, and bottles of 500, NDC 0364-2033-05.
CODE
LOT NUMBER
EXP. DATE
P9A0015
JAN 01, BOTTLES OF 50
P9A0015
OCT 00, UNIT DOSE
P9A0018
JAN 01, BOTTLES OF 50 & 500
MANUFACTURER Danbury Pharmacal Puerto Rico, Inc., Subsidiary
of Schein Pharmaceutical, Inc., Humacao, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY a) 9,378 bottles of 50, and 745 unit dose cartons
of 100; b) 13,781 bottles of 50 and 4,302 bottles of 100 were distributed;
firm estimated fewer than 0.1% of the product remained on market at time
of recall initiation.
REASON Stability; Product Fails (Exceeds) USP water content
at 9 month test point.
WEEK ENDING JUNE 23
PRODUCT Herbal Dietary Supplements: a) Zhen Qi,
Herbal Extract Capsules, 500 mg capsules, in 60-unit bottles; b) Diabetes
Angel Pearl Hypoglycemic Capsules, 0.5 grams per capsule, in 60-unit bottles;
c) Diabetes Angel Hypoglycemic Capsules, 0.5 grams per capsule, in 60-unit
bottles.
CODE All lot codes.
MANUFACTURER Tongyi Tang Pharmaceuticals Company, Harbin,
China.
RECALLED BY Sino American Health Products, Inc., Torrance,
California
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Misbranded - All three products contain the undeclared
prescription ingredient glyburide.
PRODUCT Goldline brand Acetaminophen Suppositories,
USP, OTC indicated for the temporary relief of fever, ache, pains, and
headaches, for rectal administration:
a) 120 mg, Pediatric, units of 12, NDC #0182-1662-11;
b) 650 mg, units of 12, NDC #0182-1095-11.
CODE Lot #AL 606 EXP 9/20/02.
MANUFACTURER Clay-Park Labs, Inc. (CPL), Bronx, New York.
DISTRIBUTION Kentucky.
QUANTITY 49,392 suppositories were distributed.
REASON Misbranding - Some 650 mg (correctly labeled)
suppositories were packaged into cartons labeled as 120 mg.
PRODUCT Vasotec Tablets (Enalapril Maleate), 5
mg, in 1,000 and 10,000 tablet bottles, Rx indicated for the treatment
of hypertension, it is also indicated for the treatment of symptomatic
congestive heart failure usually in combination with diuretics and digitalis.
CODE Lot Numbers: K0634 EXP 12/01 and K0635 EXP 12/01.
MANUFACTURER Merck Manufacturing Division, Division of
Merck & Company, Inc., Caguas, Puerto Rico.
DISTRIBUTION Florida, Nevada, New Mexico, Texas, Arizona,
South Dakota, Illinois.
QUANTITY 149 units were distributed.
REASON Dissolution (low) failure.
PRODUCT Nasacort AQ (Triamcinolone Acetonide) Nasal
Spray, Rx indicated for the treatment of the nasal symptoms of seasonal
and perennial allergic rhinitis in adults and children 6 years of age and
older. The NDA number is 20-468.
a) Nasacort AQ , Nasal Spray (Triamcinolone acetonide-16.5
grams), 120 metered actuations; b) Nasacort AQ , Nasal Spray (Triamcinolone
acetonide-6.5 grams), 30 metered actuations,
CODE a) All lots with expiration dates March 2000(03/2000)
through November 2001 (11/2001); b) All lots with expiration dates March
2000(03/2000) through January 2002 (01/2002).
MANUFACTURER Rhone Poulenc Rorer Puerto Rico, Inc., Manati,
Puerto Rico.
RECALLED BY Aventis Pharmaceuticals Products, Inc., Collegeville,
Pennsylvania
DISTRIBUTION Nationwide and international.
QUANTITY 11,870,820 units were distributed; firm estimated
that 350,000 units remained on market at time of recall initiation.
REASON Stability: (Super-potency) potential for patients
to receive a higher dose than labeled of triamcinolone acetonide.
WEEK ENDING JUNE 30
PRODUCT a)UriTAB(tm) Caplets (Phenazopyridine
HCL 95 mg), 30 caplet box, OTC, for urinary pain relief; b)PremeTAB(tm)
Tablets (Acetaminophen 500 mg, Pamabrom 25mg, Pyrilamine Maleate 15 mg)
15 tablet units, OTC, for use I n premenstrual discomfort;
c) PrevenTAC(tm) Caplets (Aspirin 81 mg), 30 caplets,
OTC, to help in the prevention of heart disease and heart attacks; d) SomaTAC(tm)
Caplets (Diphenhydramine Hydrochloride 50 mg), 15 caplets, OTC, helps relieve
occasional sleeplessness due to stress, anxiety, restlessness, and irritability
CODE a) Lot #J15460; b) Lot #J15466; c) Lot #J16148;
d) Lot #J15548.
MANUFACTURER Formulex Canada, Inc., Villemont-Royal,
Quebec, Canada (contract manufacturer).
RECALLED BY Olus Laboratories, Farmingdale, New York
(responsible firm)
DISTRIBUTION a) Connecticut, New Jersey, Oregon; b) Connecticut,
New Jersey, New York, Oregon; c) Connecticut, Florida, Georgia, New Jersey,
New York, North Carolina, Oregon, Pennsylvania, Texas; d) Connecticut,
New Jersey, Oregon.
QUANTITY a) 77 cases, 24 blister packs of 30 caplets
each per case; b) 89 cases, 24 blister packs of 15 tablets each per case;
c) 593 cases, 24 blister packs of 30 caplets each per case; d) 97 cases,
24 blister packs of 15 caplets each per case were distributed.
REASON Products are unapproved new drugs.
PRODUCT a) Glyburide Tablets (micronized), USP,
1.5 mg, 100 tablets, unit dose, Rx; b) Glyburide Tablets (micronized),
USP, 3 mg, 100 tablets, unit dose,. Products are indicated as an adjunct
to diet to lower the blood glucose In patients with non-insulin dependent
diabetes mellitus (type II) whose hyperglycemia cannot be satisfactorily
controlled alone. NDC Numbers: 55953-034-41 and 55953-035-41.
CODE Lot Numbers: a) 114058B EXP 10/00, 114059B EXP 10/00,
114060B EXP 10/00, and 116884A EXP 4/01; b) 114061D EXP 4/01, 114062D EXP
4/01, 114063D EXP 4/01, 114517B EXP 5/01, and 116893A EXP 12/01.
MANUFACTURER Novopharm, Ltd., Toronto, Canada.
RECALLED BY Teva Pharmaceuticals USA, Sellersville, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 1,386 units were distributed; firm estimated
that 5 percent of product remained on market at time of recall initiation.
REASON Impurity failure (12 month stability testing).