Safety Alerts & Recalls

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Actavis Mid Atlantic LLC Recalls Several Lots of Prometh VC Plain and Prometh with Codeine
Actavis Mid Atlantic LLC has recalled several lots of Prometh VC Plain (Promethazine, Phenylephrine) and Prometh with Codeine (Promethazine, Phenylephrine and codeine). The following lot numbers have been recalled because these lots did the meet the manufacturer’s routine stability tests: X111001, X111008, X111030, X110042, X110051, and X110064. Prometh VC Plain contains the active ingredient promethazine, phenylephrine and Prometh with Codeine contains promethazine, phenylephrine, and codeine. These medicines are commonly used in the treatment of cough. This recall alert only applies to the select lots of Prometh VC Plain and Prometh with Codeine. No other promethazine, phenylephrine, and codeine products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62827&w=10172012&lang=eng
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Recall on Several Lots of Propafenone 150 mg, 225 mg, and 300 mg Tablets
The ETHEX Corporation has voluntarily recalled several lots of PROPAFENONE (also called Rythmol) 150 mg, 225 mg and 300 mg tablets. These tablets may be oversized and contain more drug than appropriate. This could result in patients receiving as much as twice the expected dosage of this drug. The lot numbers involved in the recall are: Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from March 2009 to March 2011 Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from March 2009 to February 2011 Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from June 2009 to March 2011 For more information, please visit: http://www.fda.gov/oc/po/firmrecalls/ethex11_08.html
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Date Published Title Drug Source
2012-10-30 Actavis Mid Atlantic LLC Recalls Several Lots of Prometh VC Plain and Prometh with Codeine FDA
2008-11-10 Recall on Several Lots of Propafenone 150 mg, 225 mg, and 300 mg Tablets Propafenone Manufacturer
2009-01-29 Recall on All ETHEX Brand Propafenone Tablets Propafenone Manufacturer
2009-03-24 Recall on Single Lot of Propafenone 225 mg Tablets Propafenone FDA
2010-11-19 FDA Recommends Against the Continued Use of Propoxyphene (Darvon, Darvocet, and Others) Propoxyphene HCl FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Propoxyphene HCl and Acetaminophen FDA
2009-07-07 FDA Takes Actions on Pain Medications Containing Propoxyphene Propoxyphene HCl and Acetaminophen FDA
2009-06-04 Risk of Serious Liver Injury From Propylthiouracil Propylthiouracil FDA
2010-04-21 Propylthiouracil: FDA Requires Addition of Boxed Warning About Reports of Severe Liver Injury Propylthiouracil FDA
2007-10-12 Voluntary recall of OTC cough and cold medicines for infants Pseudoephedrine Manufacturer
2008-01-17 FDA recommendation regarding use in children Pseudoephedrine FDA
2010-03-31 Rugby Laboratories Recalls Select Lots of Children's Nasal Decongestant Liquid Pseudoephedrine FDA
2011-02-25 Recall of Certain Lots of SUDAFED 24 Hour Pseudoephedrine Manufacturer
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2012-12-03 Raritan Pharmaceuticals Recalls Several Lots of Store Branded Fiber Supplements Psyllium Husk FDA
2008-08-14 Weight gain associated with use of antipsychotics Quetiapine MediGuard CRT
2009-01-15 Newer Antipsychotics Linked to Heart Risks Quetiapine MediGuard CRT
2009-04-10 Recall of Seroquel XR (quetiapine fumarate) 50mg Samples Quetiapine Manufacturer
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Quetiapine MediGuard CRT
2009-10-29 Newer Antipsychotics Associated with Significant Weight Gain With Short-Term Use in Children and Adolescents Quetiapine MediGuard CRT
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