April 2012 Drug Information Update - Pharmacy Benefits ...
April 2012 Drug Information Update - Pharmacy Benefits ...
April 2012 Drug Information Update - Pharmacy Benefits ...
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December 29, 2011. Firm initiated recall is ongoing.<br />
REASON<br />
Impurities/Degradation Products: Product contains residual by-products of the manufacturing<br />
process which were above allowances.<br />
PRODUCT (Class II)<br />
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr),<br />
1 patch per pouch (NDC 54092-554-01), packaged in 30-count patches per box (NDC 54092-<br />
554-30), Rx only. Recall # D-1259-<strong>2012</strong><br />
CODE<br />
Lot #: 47313, Exp 07/12; 47937, Exp 08/12; 47955, Exp 09/12<br />
RECALLING FIRM/MANUFACTURER<br />
Noven Pharmaceuticals, Inc., Miami FL, by letter dated March 2011. Firm initiated recall is<br />
ongoing.<br />
REASON<br />
Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force<br />
and/or the z-statistic.<br />
PRODUCT (Class II)<br />
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr),<br />
1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-<br />
555-30), Rx only. Recall # D-1260-<strong>2012</strong><br />
CODE<br />
Lot # 50890, 50894, Exp 12/12<br />
RECALLING FIRM/MANUFACTURER<br />
Noven Pharmaceuticals, Inc., Miami, FL, by letter dated September 2011. Firm initiated is<br />
ongoing.<br />
REASON<br />
Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force<br />
and/or the z-statistic.<br />
PRODUCT (Class II)<br />
VALPROIC ACID ORAL SOLUTION, USP, 250 mg/5 mL, 16 fl oz (473 mL), Rx only, NDC<br />
50383-792-16 (Hi-Tech label), and NDC 0591-0426-16 (Watson label). Recall # D-1262-<strong>2012</strong><br />
CODE<br />
Lot 604482, exp. 1/2013<br />
RECALLING FIRM/MANUFACTURER<br />
Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone on December 8, 2010 and December<br />
14, 2010, and by letters dated December 8, 2010. Firm initiated recall is ongoing.<br />
REASON<br />
Failed pH Specification: OOS pH (low) resulted in OOS description for cloudy, hazy, oily<br />
appearance of the product.<br />
PRODUCT (Class II)<br />
Phenylephrine HCl Injection, USP, 1% (10 mg/mL) (50 mg/5 mL), 5 mL Vial, For <strong>Pharmacy</strong><br />
Use Only, For SC, IM, or IV use, Rx Only, NDC 0517-0405-25. Recall # D-1264-<strong>2012</strong><br />
CODE<br />
28