(grrr just lost this posting)

Reading the first posting led me to Apotec's web site. This drug company has its manufacturing facility in Toronto, Canada. The FDA has forced them to suspend production of many of their products, including Apo-Levocarb and Apo-Levocarb CR due to dificiencies at the manufacturing facility. Production for the l dopa generic was suspended in Novemever. The individual with whom I spoke did not know when manufacturing would resume. He did say there is a shortage of their product everywhere; the US, UK, Canada, AUstralia, etc. Pharmacists have been directed to substitute other generics for their product. He reiterated several times that they were following the FDA process; the inference was that the FDA was dragging its feet thru this process (or perhaps the compnay is just anxious to resume manufacturing. It is not just APO-LEVOCARB that has been suspended.)

Recall Posting Date
2009/12/21
Trade Name
Apo-Levocarb CR
Recalling Firm
Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date
2009/11/30
DIN, NPN, DIN-HM
DIN 02245211
Hazard Classification
Type II
Dosage Form
Tablets
Strength
Carbidopa - 50 mg
Levodopa - 200 mg
Lot Number
All live batches
100's - HN8694, HH8695, HN8696, HR7081, HR7083, HV1089, HV1096, HY7843, JA8415, JA8417, JC2860, JE3728, JE3729, JE3730, JF0050, JF0051

500's - HN8691, HN8692, HR7082, HV1091, JA8416, JA8418, JC6779, JE3732, JE3733, JF0049
Marketing Authorization Holder
Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall
Routine stability monitoring detected failing dissolution results for four batches.
Depth of Recall - Distribution
Canada, Barbados (JC2860), Dominica (HV1089), United Arab Emirates (HV1096, HY7843, JA8415, HV1091)
http://www.hc-sc.gc.ca/dhp-mps/compl...c_2009-eng.php