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SafetyAlerts
December 20, 2001

ETHEX Corporation Has Recalled Pangestyme Capsules

St. Louis, MO (SafetyAlerts) - The Food and Drug Administration (FDA) said that ETHEX Corporation has recalled Pangestyme Capsules.

PRODUCT
a. Pangestyme Capsules (Ethex brand) UL12 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 12,000 USP units lipase, 39,000 USP units amylase, and 39,000 USP units protease, packaged in 12-capsule bottles, NDC #58177-048-10, and 100-capsule bottles, NDC #58177-048-04, RX. Recall # D-052-2;

b. Pangestyme Capsules (ETHEX brand) UL18 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 18,000 USP units lipase, 58,500 USP units amylase, and 58,500 USP
units protease, packaged in 100-capsule bottles, NDC #58177-049-04, RX only. Recall # D-053-2;

c. 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.

d. 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-capsule bottles, NDC #58177-028-04, RX only. Recall # D-055-2;

e. Pangestyme Capsules (ETHEX brand) EC Pancrelipase Enteric Coated 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.

All bottles are labeled as Manufactured by KV Pharmaceutical Co. for ETHEX Corporation, St. Louis, MO.

CODES:
a. Pangestyme UL12
Lot 28462, Exp. 04/02
Lot 28463, Exp. 04/02
Lot 32515, Exp. 11/02

b. Pangestyme UL18
Lot 28465, Exp.04/02
Lot 28466, Exp. 06/02
Lot 28467, Exp. 06/02
Lot 29888, Exp. 06/02

c. 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

d. 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

e. 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

RECALLING FIRM/MANUFACTURER
Manufacturer:
KV Pharmaceutical Co. St. Louis, MO

Recalling Firm:
ETHEX Corporation St. Louis, MO, by Fax and letter on 10/3/01. Firm-initiated recall ongoing.

REASON:
Subpotency (Stability)

VOLUME OF PRODUCT IN COMMERCE
a) UL12 - 4,581 btls;
b) b) UL18 - 3,474 btls;
c) c) MT16 - 9,016 btls;
d) d) UL20 - 6,462 btls;
e) e) EC - 22,723 btls

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.