DRUG RECALLS : JANUARY 2012
JANUARY 2012: Over-the-counter products Exedrin, Bufferin, Gas-X Prevention and NoDoz being recalled because reports were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or capsules. Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength can result in a overdose.
JANUARY 2012: opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site such as
- Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
- Opana (oxymorphone hydrochloride) CII
- Oxymorphone hydrochloride Tablets CII
- PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
- ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
- MORPHINE SULFATE Extended-Release Tablets CII
- ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
is being recalled due to these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.
JANUARY 2012:
- Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10
Lot 1942980 – Exp. Date August 2013 and Lot 1895027 – Exp. Date June 2013 - Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10
Lot 1865067 – Exp. Date May 2012 - Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10
Lot 1865069 – Exp. Date February 2012
Recalled due to discovery of visible glass particle in a limited number of vials within the lots listed above. Particulate matter in injections can be harmful when introduced into the bloodstream. Potential adverse events after intravenous administration may include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death
JANUARY 2012: Adcetris (brentuximab vedotin)recalled due to serious nature of multifocal leukoencephalopathy (PML), a new Boxed Warning highlighting this risk has been added to the drug label. The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.
JANUARY 2012:
- Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml
- Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
- Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
- Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
- Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL
Recalled due to being unapproved drugs under FDA's regulations, and may present potential health hazards such as skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.
JANUARY 2012: Vagifresh Ball, and Vagifresh Gel recalled due to undeclared drug ingredient named benzocaine, an active ingredient for many anesthetic drug products. This product contains a bacterial contamination.
JANUARY 2012: Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012 recalled due to particular matter in vial which has been identified as glass fragments. Potential adverse events after intravenous administration of solutions containing particulates may present as an emboli and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro or macrovasular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised.
