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Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846,77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284
Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04: Lots 91762(previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333,83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272,and 91763 through 91765.
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No report of unexpected side effects or injury has been received.However, opioids such as morphine, have life-threatening consequences ifoverdosed. Those consequences can include respiratory depression (difficultyor lack of breathing), and low blood pressure, apnea, and hypotension.
The voluntary recall follows a report that a tablet with as much as doublethe appropriate thickness was identified in a previously recalled lot. Nooversized tablets have been identified in any additional distributed lot ofthese products and, based on our investigation, there are likely to be few, ifany, oversized tablets in the recalled lots. The decision to recall theadditional lots listed above has been taken as a responsible precautionbecause of the possibility that there may be oversized tablets in those lots.
The 60 mg product is a white oval tablet with "60" on one side, and "E" onthe reverse. The 30 mg product is a pink oval tablet with "30" on one side,and "E" on the reverse.
Any customer inquiries related to this action should be addressed to ETHEXCustomer Service at 1-800-321-1705, or fax to ETHEX Customer Service at314-646-3751 or sent via email to: [email protected] withrepresentatives available Monday through Friday, 8 am to 5 pm CDT.
ETHEX Corporation has initiated recall notifications to wholesalers andretailers who have received any inventory of the recalled lots of this productwith instructions for returning the recalled product and, if they have notalready done so, they are urged to contact the number above regardingprocedures for returning the recalled product. If consumers have anyquestions about the recall, they should call the number above, theirphysician, their pharmacist or other health care provider.
This recall is being conducted with the knowledge of the Food and DrugAdministration (FDA).
Any adverse reactions experienced with the use of this product, and/orquality problems may also be reported to the FDA's MedWatch Program by phoneat 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website atwww.fda.gov/medwatch.
Safe Harbor
The information in this release may contain various forward-lookingstatements within the meaning of the United States Private SecuritiesLitigation Reform Act of 1995 ("PSLRA") and which may be based on or includeassumptions concerning KV's operations, future results and prospects. Suchstatements may be identified by the use of words like "plans", "expect","aim", "believe", "projects", "anticipates", "commit", "intend", "estimate","will", "should", "could" and other expressions that indicate future eventsand trends.
All forward-looking statements are based on current expectations and aresubject to risk and uncertainties. In connection with the "safe harbor"
