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April 2012 Drug Information Update - Pharmacy Benefits ...

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PRODUCT (Class II)<br />

1) Ventolin HFA (albuterol sulfate) 90 mcg per actuation a) 60 Actuations, NDC 0173-0682-21;<br />

b) 60 Actuations Sample, NDC 0173-0682-23; c) 60 Actuations Institutional Pack, NDC 0173-<br />

0682-24 Rx only. Recall # D-1252-<strong>2012</strong>;<br />

2) Ventolin HFA Inhaler (albuterol sulfate) 90 mcg per actuation NOVAPLUS - 60 Actuations,<br />

Rx only, NDC 0173-0682-54. Recall # D-1253-<strong>2012</strong><br />

CODE<br />

1) Lot: 1ZP0922, 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, 1ZP8151, 1ZP0856, 1ZP1981,<br />

1ZP6941, 1ZP7824, 1ZP9063;<br />

2)Lot numbers: 1ZP1061, 1ZP6940 and 1ZP9680<br />

RECALLING FIRM/MANUFACTURER<br />

GlaxoSmithKline Inc., Zebulon, NC, via letter on/about January 18, <strong>2012</strong>. Firm initiated recall is<br />

ongoing.<br />

REASON<br />

Does Not Deliver Proper Metered Dose: The affected canisters may not contain sufficient<br />

propellant to deliver the labeled claim of 60 doses.<br />

PRODUCT (Class II)<br />

Cytarabine for Injection USP, for Intravenous, Subcutaneous, or Intrathecal use, 1 gram, Rx<br />

Only, NDC 55390-133-01. Recall # D-1255-<strong>2012</strong><br />

CODE<br />

Lot #: 2066986, Exp 03/31/2014; 2111675, Exp 04/30/2014; 2131148, Exp 05/31/2014<br />

RECALLING FIRM/MANUFACTURER<br />

Ben Venue Laboratories Inc., Bedford, OH, by letter on February 15, <strong>2012</strong>, a press release on<br />

February 16, <strong>2012</strong> and a follow-up letter on February 17, <strong>2012</strong>. Firm initiated recall is ongoing.<br />

REASON<br />

Lack of Assurance of Sterility<br />

PRODUCT (Class II)<br />

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx only, NDC 0409-7972-08. Recall # D-<br />

1257-<strong>2012</strong><br />

CODE<br />

Lot Code: 09-060-JT<br />

RECALLING FIRM/MANUFACTURER<br />

Hospira, Inc., Austin, TX, by letters on February 13, <strong>2012</strong>. Firm initiated recall is ongoing.<br />

REASON<br />

Lack of Assurance of Sterility: there is a potential for solution to leak from the administration<br />

port of the primary container.<br />

PRODUCT (Class II)<br />

Fludeoxyglucose F18 Injection, multiple-dose glass vial containing 0.74 - 11.1 GBq (20 - 300<br />

mCi/mL), and labeled in part ***Sterile Non-pyrogenic***Radioactive. Recall # D-1258-<strong>2012</strong><br />

CODE<br />

Lot 6509, Exp 6:15 pm on 27 Dec 2011<br />

RECALLING FIRM/MANUFACTURER<br />

Precision Nuclear of Virginia, Salem, VA, by telephone on December 27, 2011 and by letter on<br />

27

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