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SafetyAlerts
May 31, 2000

Schering Laboratories Recalls Over 67 Million Inhalers

Kenilworth, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Schering Laboratories is conducting a recall of various inhalers, because some canisters may not have active ingredient.

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)

The affect batch numbers and expiration dates are:

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.

According to FDA, over 67 million units were distributed nationwide, Puerto Rico and in Canada.

This ongoing Class II recall was initiated by the company, by fax on March 29, 2000, mailgram on March 30, 2000, and by letters April 1-4, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-369/373-0

Notice of this product warning was sent via email to SafeMail subscribers May 31, 2000.

 
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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