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SafetyAlerts
May 16, 2002

ETHEX Corp Has Recalled Pangestyme Capsules

(SafetyAlerts) - The Food and Drug Administration (FDA) said that ETHEX Corp Has Recalled Pangestyme Capsules.

PRODUCT
Recall Extension for the following products:
a) Pangestyme Capsules (ETHEX brand) UL20 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 20,000 USP units lipase, 65,000 USP units amylase, and 65,000 USP units protease, packaged in 100-capsule bottles, NDC #58177-050-04, RX only. Recall # D-054-2;
b) Pangestyme Capsules (Ethex brand) MT16 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 16,000 USP units lipase, 48,000 USP units amylase and 48,000 USP units protease, packaged in 100-capsulebottles, NDC #58177-028-04, RX only. Recall # D-055-2;
c. Pangestyme Capsules (ETHEX brand) EC Pancrelipase EntericCoated Microspheres Contained in Capsules, each dye-free capsule contains 4,500 USP units lipase, 20,000 USP units amylase, and 25,000 USP units protease, packaged in 12-, 100-, and 250-capsule bottles, NDC #58177-031-10 (12's), #58177-031-04 (100's) and #58177-031-06 (250's), RX only.
Recall # D-056-2.

CODE
a) Pangestyme UL20
Lot 28642, Exp. 04/02
Lot 28643, Exp. 06/02
Lot 28653, Exp. 06/02
Lot 29930, Exp. 06/02
Lot 29931, Exp. 06/02
Lot 29932, Exp. 06/02
Recall extension lot:
Lot 34846, Exp 02/03
b) Pangestyme MT16
Lot 27478, Exp. 03/02
Lot 27479, Exp. 03/02
Lot 27480, Exp. 03/02
Lot 28639, Exp. 04/02
Lot 28640, Exp. 04/02
Lot 28641, Exp. 05/02
Lot 30245, Exp. 04/02
Recall extension lot:
Lot 35703, Exp. 03/03
c) Pangestyme EC
Lot 27487, Exp. 05/02
Lot 27488, Exp. 05/02
Lot 27489 (250-ct.), Exp. 05/02
Lot 27777, Exp. 06/02
Lot 27778, Exp. 07/02
Lot 27779 (250-ct.), Exp. 07/02
Lot 27780 (250-ct.), Exp. 08/02
Lot 30882, Exp. 07/02
Lot 30883, Exp. 07/02
Lot 30934, Exp. 07/02
Recall extension lots:
Lot 30884, Exp 12/02
Lot 31558, Exp 12/02
Lot 32562, Exp 01/03
Lot 34399, Exp 01/03
Lot 34796, Exp 01/03
Lot 34835, Exp 03/03
Lot 35986, Exp 04/03
Lot 35987, Exp 04/03
Lot 36499, Exp 05/03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: ETHEX Corp., St. Louis, MO, by fax and letter on October 3, 2001 and by letter dated March 4, 2002.
Manufacturer: KV Pharmaceutical Co., St. Louis, MO.
Firm initiated recall is ongoing.

REASON
Subpotency (Stability).

VOLUME OF PRODUCT IN COMMERCE
UL12 - 4,581 btls;
UL18 - 3,474 btls;
MT16 - 10,899 btls;
UL20 - 8,728 btls;
EC - 50,070 btls.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


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During 2000 there were over
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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.