Product Recall FAQs
 
Why were products recalled?

ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), has issued a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions. Suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
When will ETHEX products be available on the market again?

We are working to resume shipments as quickly as possible. At this time, the company is unable to determine when distribution of these products will resume.
Is it safe to continue taking ETHEX prescription medications?

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions. Suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these medications, or to obtain replacement medications or prescriptions.
What ETHEX products were recalled?
The following ETHEX products were recalled:
   

Products Recalled to the Wholesale Level :

Advanced NatalCare RF Tablets (58177-458-26) *
Advanced NatalCare Tablets (58177-350-26)
Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11) *
Amlodipine Besylate Tablets, 2.5mg (58177-536-26) *
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07, 537-11) *
Anemagen Caplets (58177-672-26)
Anemagen Forte Caplets (58177-671-26)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04, 091-08 & 091-11)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04) *
Bromfenex PD ER Capsules (58177-020-04) *
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)
Cal-Nate Tablets (58177-935-26)
CareNatal DHA Tablets (58177-618-66)
Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04) *
ComBgen Tablets (58177-440-04)
CombiRx Tablets (58177-670-19)
Conison Capsules (58177-044-03)
Diltiazem HCl Capsules, 120mg (58177-061-11) *
Diltiazem HCl Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HCl Capsules, 180mg (58177-062-09 & 062-11) *
Diltiazem HCl Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HCl Capsules, 240mg (58177-063-09 & 063-11) *
Diltiazem HCl Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HCl Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HCl Capsules, 360mg (58177-065-09 & 065-11) *
Diltiazem HCl Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HCl Capsules, 420mg (58177-066-09 & 066-11) *
Diltiazem HCl Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, 0.25mg (58177-432-40)
Ethedent Chewable Tablets, 0.5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65) *
Ethezyme 650 Ointment (58177-868-02) *
Ethezyme 830 Ointment (58177-816-02) *
Ethezyme Ointment (58177-804-02) *
ETH-Oxydose Concentrated Solution (58177-914-01 & 914-56)
Fe-Tinic 150 Forte Capsules (58177-967-26)
Guaifenex DM ER Tablets 600/30mg (58177-213-04) *
Guaifenex GP ER Tablets (58177-373-04) *
Guaifenex PSE 120 ER Tablets (58177-208-04) *
Guaifenex PSE 60 ER Tablets (58177-214-04) *
Guaifenex PSE 80 Tablets (58177-413-04) *
Guaifenex PSE 85 Tablet (58177-478-04) *
Hista-Vent DA Tablets (58177-227-04) *
Hista-Vent PSE Tablets (58177-426-04) *
Histenex HC Syrup (58177-877-07 & 877-12) *
Histinex PV Syrup (58177-883-07) *
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07) *
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/ Sunscreen (58177-802-02) *
Hydroquinone 4% Cream (58177-801-02) *
Hydro-Tussin CBX Syrup (58177-924-07) *
Hydro-Tussin DHC Syrup (58177-926-07) *
Hydro-Tussin DM Liquid 16oz. (58177-906-07) *
Hydro-Tussin EXP Liquid (58177-927-07) *
Hydro-Tussin HC Syrup (58177-915-07) *
Hydro-Tussin HD Liquid (58177-890-07) *
Hydro-Tussin XP Liquid (58177-916-07) *
Hyoscyamine Orally Disintegrating Tablets, 0.125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, 0.125mg (58177-255-04) *
Hyoscyamine Sulfate ER Tablets, 0.375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, 0.375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, 0.125mg (58177-274-04)
KCl 20mEq ER Tablets (58177-202-04, 202-08 & 202-09) *
KCl 20mEq ER Tablets (58177-202-11)
Meperidine/Promethazine Capsules (58177-027-04) *
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 & 886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate InveAmp, 20mg/1mL (58177-886-56) *
Morphine Sulfate InveAmp, 10mg/.50mL (58177-889-81) *
Morphine Sulfate InveAmp, 5mg/.25mL (58177-888-80) *
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NataCaps Capsules (58177-073-04)
NatalCare Gloss Tablets (58177-418-26) *
NatalCare PIC Forte Tablets (58177-258-04)
NatalCare PIC Tablets (58177-257-04) *
NatalCare Plus Tablets (58177-225-04)
NatalCare RX Tablets (58177-317-05) *
NatalCare Three Tablets (58177-415-04) *
NataTab FA Tablets (58177-329-04) *
NataTab Rx Tablets (58177-376-26)
NitroQuick Sublingual Tablets, 0.3mg (58177-323-04)
NitroQuick Sublingual Tablets, 0.4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, 0.6mg (58177-325-04)
NutriNate Chewable Tablets (58177-351-26)
NutriSpire Tablets (58177-463-26)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 Delayed-Release Capsules (58177-030-04)
Pangestyme CN10 Delayed-Release Capsules (58177-029-04)
Pangestyme EC Delayed-Release Capsules (58177-031-04)
Pangestyme EC Delayed-Release Capsules (58177-031-06)
Pangestyme MT16 Delayed-Release Capsules (58177-028-04)
Pangestyme UL12 Delayed-Release Capsules (58177-048-04)
Pangestyme UL18 Delayed-Release Capsules (58177-049-04)
Pangestyme UL20 Delayed-Release Capsules (58177-050-04)
PhenaVent Capsules (58177-078-19) *
PhenaVent D Tablets (58177-444-04) *
PhenaVent LA Capsules (58177-095-19) *
PhenaVent PED Capsules (58177-079-04) *
Plaretase 8000 Tablets (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
PrednisoLONE Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Prenatal MR90 FE Tablets (58177-212-04)
Prenatal MTR w/Selenium Tablets (58177-316-04) *
Prenatal Rx 1 Tablets (58177-216-04 & 216-11)
Prenatal Z Tablets (58177-275-04)
Pseudovent 400 Capsules (58177-096-04) *
Pseudovent Capsules (58177-045-04) *
Pseudovent PED Capsules (58177-046-04) *
Tri-Vent DM Syrup (58177-925-07) *
Tri-Vent DPC Liquid (58177-923-07) *
Tri-Vent HC Liquid (58177-920-07) *

Products Recalled to the Retail Level:

Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04) *
Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04) *
Isosorbide Mononitrate ER Tablets, 30mg (58177- 222-11)
Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-12) *
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-12) *
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Morphine IR Tablets 15mg & 30mg (58177-313-04 & 314-04)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Ultra NatalCare Tablets (58177-292-04) *

* Denotes product that was discontinued prior to February 3, 2009.

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The recall announcement is posted on www.kvpharma.com.
 
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