Alerts

FDA MedWatch - Heparin and Normal Saline Pre-Filled Flushes- Nationwide Recall Because One Lot Was Contaminated With Bacteria

AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.

Read the complete 2008 MedWatch Safety Summary including a link to the Manufacturer's Recall Notice regarding this issue at:
www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART).

Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.

Read the complete MedWatch 2007 Safety summary, including links to the Manufacturer's Dear Healthcare Provider Letter and revised labeling, at: www.fda.gov/medwatch/safety/2007/safety07.htm#Baraclude

Recalls

For the latest recall information from the FDA click here.

Individual Recall Notices:

October 2007 Recalls:

Recall: 2007-105 -Azur Pharma, Inc., is conducting a recall of the FazaClo 100mg tablets packaged in 100 count cartons, labeled as Unit Dose Child Resistant Blisters, NDC 68322-002-04, with Lot Number 370522. Only product labeled with both NDC 68322-002-04 and Lot Number 370522 is being recalled.

Recall: 2007-106 -Teva Pharmaceuticals USA, Inc., is voluntarily recalling lots of Methylprednisolone Acetate Injection Suspension, USP 80mglmL, lmL distributed under the Teva Pharmaceuticals label. This recall is being carried out to the RETAIL LEVEL and is due to a lack of sterility assurance.

Recall: 2007-110 - McNeil Consumer Healthcare is voluntarily withdrawing products listed. It is believed that the decision to voluntarily withdraw the products may help reduce instances of misuse leading to overdose in children under two years of age.

Recall: 2007-111 - Novartis Consumer Health, Inc. (NCH) is conducting a voluntary withdrawal of its two infant cough and cold products: Triaminic® Infant & Toddler Thin Strips® Decongestant, and Triaminic® Infant and Toddler Thin Strips® Decongestant Plus Cough, as part of an industry-wide initiative.

Recall: 2007-112 - Medtech Products, Inc., as part of an industry wide recommendation, is announcing the voluntary market withdrawal of two medicated over-the-counter infant oral cough and cold products, to improve labeling and encourage proper use of these products in children. The voluntary withdrawal by Medtech and the entire industry is a cautionary step to address reports of misuse of oral cough and cold products in infants.

Recall: 2007-113 - Schering-Plough Healthcare Products is conducting a voluntary recall of four (4) specific lots of Children's Claratin Allergy Oral Solution-Grape (Loratadine Oral Solution 5mg/5mL antihistamine). Schering-Plough HealthCare Products, NJ, is taking this action because of degradation of the active pharmaceutical ingredient in these four lots detected during routine stability studies.

Recall: 2007-114 - King Pharmaceuticals, Inc., has voluntarily recalled Penicillin G Procaine Injectable Suspension for certain lot numbers. This recall was initiated when it was discovered that the carton was mislabeled in that it stated the product strength as both 1,200,000 unitsl2mL and 1,200,000 units/lmL on the carton.

Recall: 2007-115 - Hospira, Inc., is voluntarily recalling lot number 54-565-LL associated with the products identified in this recall. These products are ImL Carpujects® with Luer Locks. This lot was distributed between August and October 2007 and has an expiration date of June 1,2009.

Recall: 2007-103A - McNeil Consumer Healthcare Division of MCNEIL-PPC, Inc., is recalling the these lot numbers because of a non-conformance with product dosage uniformity.

Recall: 2007-118 - Wyeth Consumer Healthcare is voluntarily withdrawing Dimetapp Decongestant Infant Drops, Dimetapp Decongestant Plus Cough Infant Drops, Robitussin Infant Cough DM and Robitussin Infant Cough & Cold CF.

Recall: 2007-119 - Ranbaxy Pharmaceuticals, Inc., is conducting a voluntary recall of all Gabapentin Tablets, 600mg and 800mg lots due to out-of specification for the "Related Substances" limit as specified in the products approved specification.

Recall: 2007-120 - Wyeth Consumer Healthcare is voluntarily recalling all lots of the listed products. Wyeth is voluntarily recalling these lots from the market as these products do not contain a dosing cup with a 1/2-teaspoon mark and the dosing instructions on the labeling include a 1/2-teaspoon every 4 hours for children 2 years to under 6 years. In addition to the lots that were sold as open stock, some of the lots were also sold in the display lots listed above.

Recall: 2007-123 - Parenta Pharmaceuticals is conducting a voluntarily withdrawal as a result of routine stability testing that detected an impurity that was approaching an unacceptable level. As a result, Parenta is taking a proactive approach and is withdrawing this specific lot of the product. Please note that the lot was distributed in March and April of 2006. No additional lots are affected at this time.

November 2007 Recalls:

Recall: 2007-124 - The product lot T755 distributed by E. Fougera & Company is subject to a voluntary recall by Altana, Inc., due to an out-of-specification stability test result (for homogeneity).

Recall: 2007-130 - IV AX Pharmaceuticals, Inc., is voluntarily recalling these product lots due to not meeting assay or impurity specifications.

Recall: 2007-131 - Forest Pharmaceuticals, Inc., manufacturer of Armour Thyroid Tablets, is voluntarily recalling the lot numbers listed on recall due to two lots failing the disintegration stability test at the 6-month testing interval.

Recall: 2007-132 - Inwood Laboratories, Inc., manufacturer of Theophylline Extended Release Capsules, (distributed byInwood Laboratories, Inc.) is voluntarily recalling these lots of Theophylline ER Capsules. The reason for this recall is because of an out of acceptance limit on individual capsule identified during 12-month stability testing or lack of assurance product lot will meet shelf life.

Recall: 2007-133 - Greenstone Ltd., is recalling the referenced lot of Glyburide 5mg Tablets; Greenstone Ltd"vo1untarily initiated this recall when it was determined that these lots may not meet dissolution specifications on stability. Please note that when using this product as directed, the probability of serious adverse health consequences is remote. The lots were shipped between October 2006 and October 2007.

December 2007 Recalls:

Recall: 2007-132A - Inwood Laboratories, Inc., manufacturer of Theophylline Extended Release Capsules, (distributed byInwood Laboratories, Inc.) is voluntarily recalling additional lots of Theophylline ER Capsules.

Recall: 2007-140 - Apotex, Inc., is voluntarily recalling the these product lots because ongoing monitoring has determined that the lots have a level of related compounds marginally in excess of the specification limit; therefore, are being voluntarily recalled from the market. No other lots, package sizes, strengths, or products are affected by this recall. The level of related compounds is expected to have no significant adverse health consequences.

Recall: 2007-141 - Valeant Pharmaceuticals is voluntarily recalling specific lots of the listed product from the market due to carton/vial label discrepancies. Although the true stability of the product is accurately reflected on the outer carton of the product, the discrepancy between carton and vial label expiration dates has raised the possibility of patient confusion.

January 2008 Recalls:

Recall: 2008-001 - First Aid Only, Inc., is conducting a voluntary recall of First Aid Only branded first aid kits and/or refills. These first aid kits and/or refills contain ibuprofen tablets, 200mg, 2 tablets per pack, that were recalled by Generic Pharmaceutical Services, Inc., due to failing USP limit for impurity during stability testing. The manufacturer, Interpharm, Inc., has indicated that while the failure at this level does not constitute a health hazard, it is a failure in the impurity limits as approved in their standards.

Recall: 2008-008 - Hospira, Inc., is initiating a voluntary market withdrawal of two lots of Endrate (Edetate Disodium Injection, USP) 150mg/mL packaged in 20mL ampuls identified above. These products were distributed between August 2005 and December 2007.

Recall: 2008-009 - Baxter Healthcare is voluntarily recalling lots of Heparin as a precaution, due to an increase in reports of adverse patient reactions including the following: abdominal pain, abdominal pain (upper), decreased blood pressure, burning sensation, and chest pain. Reports also included: diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.

Recall: 2008-009A - This notification is not an expansion to the original recall. This notification is only to clarify that the individual vial NDC's are different from the 25 shelf pack NDC's.

Recall: 2008-011 - B. Braun Medical, Inc., was recently notified by their contract manufacturer, AM2PAT, Inc., of a nationwide recall of all lots of Pre-Filled Heparin and Normal Saline Syringes. AM2PAT, Inc., manufactures these pre-filled syringes under both of their private labels: Sierra Pre-Filled, Inc., and B. Braun Medical, Inc. Based on an ongoing FDA inspection of AM2PAT Inc.'s facility, it has been determined that there is a potential for the sterility of these lots to be compromised, which may result in potential contamination. This issue may result in patient injury.

February 2008 Recalls:

Recall: 2008-013 - Richmond Pharmaceuticals, Inc., is recalling lots of Perphenazine that is manufactured by Vintage Pharmaceuticals, LLC. Vintage Pharmaceuticals, LLC has recalled Perphenazine Tablets, USP 8mg and 16mg, due to cracks in the coating of some of the tablets and some of the tablets splitting.

Recall: 2008-014 - Teva Pharmaceuticals USA, Inc., is voluntarily recalling the lot of Megestrol Acetate Oral Suspension 40mg/mL distributed under the Teva Pharmaceuticals label. This recall is being carried out to the Retail Level and is due to an out of specification assay result.

Recall: 2008-015 - Chattem, Inc., is recalling these products because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from the use or possible misuse of these products.

Recall: 2008-016 - Based on ALZA Corporation's recall, Sandoz Inc., is notifying all direct customers of this voluntary recall of the product because the lots may have cuts along one side of the drug reservoir. The result is the possibility of gel being released from the gel reservoir into the pouch that the patch is packaged in, resulting in direct exposure to the Fentanyl gel by patients or caregivers. Exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Recall: 2008-018 - Tri-Med Laboratories, manufacturer of the this product which is distributed by Major Pharmaceuticals, is recalling the product lot at the retai1 1evel. This recall was initiated because during the 18-month room temperature stability testing for fungi, count was found to be higher than the limit.

Archived Recalls