MARCH 2010
WEEK ENDING MARCH 27
PRODUCT
Oxygen Compressed U. S. P. UN 1072, Gas: 7782-44-7, Oxygen 2, is stored in B, C,
D and E-size tanks, Rx only.
CODE
B-TANKS: Serial numbers with dates: 2632 11/1/2009; 4929 11/1/2009; 5454
11/1/2009; 681 11/3/2009; 1098 11/3/2009; 2488 11/3/2009; 2490; 11/3/2009; 3154
11/3/2009; 4313 11/3/2009; 5096 11/3/2009; 5336 11/3/2009; 851 11/4/2009; 1095
11/4/2009; 1250 11/4/2009; 2061 11/4/2009; 3074 11/4/2009; 3580 11/4/2009; 3674
11/4/2009; 3929 11/4/2009; 4409 11/4/2009; 4503 11/4/2009; 4553 11/4/2009; 4567
11/4/2009; 4783 11/4/2009; 4946 11/4/2009; 4949 11/4/2009; 84 11/5/2009; 844
11/5/2009; 1057 11/5/2009; 1144 11/5/2009; 1148 11/5/2009; 1228 11/5/2009; 3462
11/9/2009; 3698 11/9/2009; 3926 11/9/2009; 4224 11/9/2009; 4359 11/9/2009; 4398
11/9/2009; 4410 11/9/2009; 4675 11/9/2009; 4751 11/9/2009; 5087 11/9/2009; 5141
11/9/2009; 5147 11/9/2009; 5260 11/9/2009; 5435 11/9/2009; 1018 11/10/2009; 3438
11/10/2009; 3682 11/10/2009; 3851 11/10/2009; 3858 11/10/2009; 3889 11/10/2009;
3980 11/10/2009; 3990 11/10/1009; 4598 11/10/2009; 5006 11/10/2009; 5312
11/10/2009; 5323 11/10/2009; 922 11/11/2009; 981 11/11/2009; 1835 11/11/2009;
1863 11/11/2009; 2510 11/11/2009; 2911 11/11/2009; 3276 11/13/2009; 3277
11/13/2009; 3427 11/13/2009; 3491 11/13/2009; 3503 11/13/2009; 3504 11/13/2009;
3634 11/13/2009; 3667 11/13/2009; 3772 11/13/2009; 3780 11/13/2009; 3801
11/13/2009; 3817 11/13/2009; 3828 11/13/2009; 3888 11/13/2009; 4255 11/13/2009;
4334 11/13/2009; 4459 11/13/2009; 4471 11/13/2009; 4489 11/13/2009; 4496
11/13/2009; 4501 11/13/2009; 4563 11/13/2009; 4581 11/13/2009; 4604 11/13/2009;
4608 11/13/2009; 4613 11/13/2009; 4629 11/13/2009; 4641 11/13/2009; 4664
11/13/2009; 4669 11/13/2009; 4704 11/13/2009; 4755 11/13/2009; 5415 11/17/2009;
5440 11/17/2009; 811 11/18/2009; 1007 11/18/2009; 1052 11/18/2009; 1240
11/18/2009; 1321 11/18/2009; 1984 11/18/2009; 2209 11/18/2009; 2700 11/18/2009;
3283 11/18/2009; 3891 11/18/2009; 3928 11/18/2009; 3957 11/18/2009; 3970
11/18/2009; 4244 11/18/2009; 4293 11/18/2009; 4309 11/18/2009; 4583 11/18/2009;
4632 11/18/2009; 4636 11/18/2009; 4694 11/18/2009; 4746 11/18/2009; 4804
11/18/2009; 4860 11/18/2009; 4937 11/18/2009; 4964 11/18/2009; 5138 11/18/2009;
5156 11/18/2009; 5246 11/18/2009; 5259 11/18/2009; 5268 11/18/2009; 2190
11/5/2009; 2379 11/5/2009; 2704 11/5/2009; 3055 11/5/2009; 3233 11/5/2009; 3468
11/5/2009; 3508 11/5/2009; 3659 11/5/2009; 3855 11/5/2009; 3856 11/5/2009; 3909
11/5/2009; 3915 11/5/2009; 3958 11/5/2009; 4102 11/5/2009; 4295 11/5/2009; 4329
11/5/2009; 4344 11/5/2009; 4438 11/5/2009; 4512 11/5/2009; 4521 11/5/2009; 4590
11/5/2009; 4687 11/5/2009; 4789 11/5/2009; 5227 11/5/2009; 5393 11/5/2009; 2
11/6/2009; 3 11/6/2009; 967 11/6/2009; 1004 11/6/2009; 1440 11/6/2009; 2069
11/6/2009; 2583 11/6/2009; 2831 11/6/2009; 2931 11/6/2009; 3053 11/11/2009; 3265
11/11/2009; 3593 11/11/2009; 3601 11/11/2009; 3861 11/11/2009; 3865 11/11/2009;
3933 11/11/2009; 4239 11/11/2009; 4413 11/11/2009; 4702 11/11/2009; 4757
11/11/2009; 4782 11/11/2009; 4976 11/11/2009; 5325 11/11/2009; 5364 11/11/2009;
5366 11/11/2009; 5444 11/11/2009; 5446 11/11/2009; 125 11/12/2009; 147
11/12/2009; 199 11/12/2009; 502 11/12/2009; 517 11/12/2009; 548 11/12/2009; 641
11/12/2009; 643 11/12/2009; 767 11/12/2009; 1042 11/12/2009; 1438 11/12/2009;
1459 11/12/2009; 1478 11/12/2009; 1880 11/12/2009; 1982 11/12/2009; 2010
11/12/2009; 4756 11/13/2009; 4797 11/13/2009; 4948 11/13/2009; 4996 11/13/2009;
5105 11/13/2009; 5111 11/13/2009; 5136 11/13/2009; 5171 11/13/2009; 5257
11/13/2009; 5264 11/13/2009; 5280 11/13/2009; 58 11/16/2009; 428 11/16/2009; 511
11/16/2009; 537 11/16/2009; 1017 11/16/2009; 1455 11/16/2009; 2461 11/16/2009;
2939 11/16/2009; 2976 11/16/2009; 3136 11/16/2009; 3237 11/16/2009; 3654
11/16/2009; 3669 11/16/2009; 3672 11/16/2009; 3912 11/16/2009; 3952 11/16/2009;
4353 11/16/2009; 4695 11/16/2009; 4828 11/16/2009; 5107 11/16/2009; 5221
11/16/2009; 5233 11/16/2009; 5324 11/16/2009; 5373 11/18/2009; 5432 11/18/2009;
235 11/19/2009; 245 11/19/2009; 506 11/19/2009; 1078 11/19/2009; 1979
11/19/2009; 2648 11/19/2009; 3029 11/19/2009; 3287 11/19/2009; 3514 11/19/2009;
3827 11/19/2009; 4249 11/19/2009; 4267 11/19/2009; 4578 11/19/2009; 4615
11/19/2009; 4744 11/19/2009; 4773 11/19/2009; 4926 11/19/2009; 4940 11/19/2009;
4970 11/19/2009; 5085 11/19/2009; 5125 11/19/2009; 5272 11/19/2009; 5282
11/19/2009; 5289 11/19/2009; 5323 11/19/2009; 5439 11/19/2009; 5443 11/19/2009;
5458 11/19/2009; 5243 11/19/2009; 4301 11/19/2009; 3061 11/6/2009; 3295
11/6/2009; 3396 11/6/2009; 4230 11/6/2009; 4264 11/6/2009; 4388 11/6/2009; 4467
11/6/2009; 4481 11/6/2009; 4492 11/6/2009; 4505 11/6/2009; 4511 11/6/2009; 4558
11/6/2009; 4573 11/6/2009; 4621 11/6/2009; 4660 11/6/2009; 5003 11/6/2009; 5086
11/6/2009; 5099 11/6/2009; 5102 11/6/2009; 5219 11/6/2009; 5237 11/6/2009; 5414
11/6/2009; 5441 11/6/2009; 5457 11/6/2009; 302 11/9/2009; 657 11/9/2009; 2380
11/9/2009; 3418 11/9/2009; 2029 11/12/2009; 2470 11/12/2009; 2598 11/12/2009;
2818 11/12/2009; 3221 11/12/2009; 3304 11/12/2009; 3431 11/12/2009; 3762
11/12/2009; 4383 11/12/2009; 4479 11/12/2009; 4666 11/12/2009; 4667 11/12/2009;
4815 11/12/2009; 4861 11/12/2009; 4996 11/12/2009; 5238 11/12/2009; 5245
11/12/2009; 140 11/13/2009; 168 11/13/2009; 1313 11/13/2009; 1322 11/13/2009;
1434 11/13/2009; 1826 11/13/2009; 2011 11/13/2009; 2665 11/13/2009; 3126
11/13/2009; 3234 11/13/2009; 3243 11/13/2009; 5271 11/16/2009; 5357 11/16/2009;
26 11/17/2009; 43 11/17/2009; 71 11/17/2009; 266 11/17/2009; 547 11/17/2009; 611
11/17/2009; 644 11/17/2009; 655 11/17/2009; 1211 11/17/2009; 1230 11/17/2009;
1342 11/17/2009; 1622 11/17/2009; 1986 11/17/2009; 2204 11/17/2009; 2833
11/17/2009; 2848 11/17/2009; 3217 11/17/2009; 3235 11/17/2009; 3291 11/17/2009;
3369 11/17/2009; 3516 11/17/2009; 3668 11/17/2009; 4441 11/17/2009; 4795
11/17/2009; 5115 11/17/2009; and 5253 11/17/2009. C-TANKS: Serial numbers and
dates: 2093 11/10/2009; 267 11/11/2009; 287 11/11/2009; 348 11/11/2009; 1465
11/11/2009; 1725 11/11/2009; 2156 11/11/2009; 2227 11/11/2009; 2242 11/11/2009;
2650 11/11/2009; 3337 11/11/2009; 3341 11/11/2009; 2809 11/12/2009; 479
11/16/2009; 36 11/17/2009; 61 11/17/2009; 1513 11/17/2009; 1672 11/17/2009; 2150
11/17/2009; 2628 11/17/2009; 3193 11/17/2009; 3343 11/17/2009; 3512 11/17/2009;
3531 11/17/2009; 5400 11/17/2009; 275 11/18/2009; 282 11/18/2009; 339
11/18/2009; 492 11/18/2009; 1212 11/18/2009; 2224 11/18/2009; 2631 11/18/2009;
2647 11/18/2009; 2849 11/18/2009; 3203 11/18/2009; 489 11/19/2009; and 817
11/19/2009.
D-TANKS: Serial numbers and dates: 161 11/17/2009; 736 11/17/2009; 1530
11/17/2009; 1940 11/17/2009; 3006 11/17/2009; 4077 11/17/2009; and 4364
11/17/2009.
E-TANKS: Serial numbers and dates: 4872 11/3/2009; 5072 11/3/2009; 1034
11/5/2009; 1163 11/5/2009; 1414 11/5/2009; 2118 11/5/2009; 2681 11/5/2009; 2921
11/5/2009; 3545 11/5/2009; 5046 11/5/2009; 4891 11/6/2009; 2071 11/9/2009; 4235
11/9/2009; 5013 11/9/2009; 5201 11/9/2009; 136 11/10/2009; 1921 11/10/2009; 2137
11/10/2009; 2909 11/10/2009; 3563 11/10/2009; 3775 11/10/2009; 4038 11/10/2009;
5398 11/10/2009; 1694 11/11/2009; 1883 11/11/2009; 1904 11/11/2009; 2045
11/11/2009; 2211 11/11/2009; 2530 11/11/2009; 2556 11/11/2009; 2559 11/11/2009;
2703 11/11/2009; 2760 11/11/2009; 2869 11/11/2009; 3184 11/11/2009; 3307
11/11/2009; 3708 11/11/2009; 4031 11/11/2009; 5030 11/11/2009; 2314 11/12/2009;
2322 11/12/2009; 3095 11/12/2009; 3569 11/12/2009; 3757 11/12/2009; 4889
11/12/2009; 4890 11/12/2009; 5076 11/12/2009; 5497 11/12/2009; 2263 11/13/2009;
2294 11/13/2009; 2331 11/13/2009; 2989 11/13/2009; 5037 11/13/2009; 5475
11/13/2009; 2230 11/15/2009; 3183 11/15/2009; 1335 11116/2009; 1714 11/16/2009;
1714 11/16/2009; 4742 11/16/2009; 5011 11/16/2009; 5208 11/16/2009; 5427
11/16/2009; 1781 11/17/2009; 2552 11/17/2009; 5019 11/17/2009; 5036 11/18/2009;
292 11/19/2009; 3190 11/19/2009; and 4905 11/19/2009
RECALLING FIRM/MANUFACTURER
Special Care Home Oxygen & Medical Equipment, Inc., Richardson, TX,
REASON
CGMP Deviations:Oxygen product has no purity test documentation and cylinder
labels did not reflect current address of the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
651 cylinders
DISTRIBUTION
TX
PRODUCT OctreoScan, Kit for the Preparation of Indium In-111
Pentetreotide, 10 mL
Reaction Vial containing 10 mcg lyophilized Pentetreotide, 10-mL Indium In-111
Chloride Sterile Solution Vial containing 1.1 mL of 111 MBq/ml (3. 0 mCi/mL)
aqueous Indium In-111 chloride, RX only. NDC 0019-9050-40.
CODE
Lot #050-0002, Exp date 11JAN10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc., Hazelwood, MO,
Manufacturer: Mallinckrodt Inc., Maryland Heights, MO.
REASON
Lack of Efficacy: The product is not performing within acceptable production
specifications (radiochemical purity).
VOLUME OF PRODUCT IN COMMERCE
119 kits
DISTRIBUTION
Nationwide
PRODUCT Fluconazole, sterile liquid, 200 mg/100 mL (2
mg/mL), 6 x 100 mL vials per box,
Rx only, NDC: 0143-9899-01.
CODE
Lot 092112.1, Exp 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ,
Manufacturer: Hikma Farmaceutica, (Portugal) S.A., Fervenca, Terrugen, Portugal.
REASON
Product Lacks Stability: Assay results for Fluconazole Injection 200 mg/100mL,
lot number 092112.1 had out of specification assay results, both high and low,
at 3 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
1456 boxes / 6 x 100ml vials per box
DISTRIBUTION
Nationwide
PRODUCT
Sea Pure 100% Natural Sheer Lotion SPF 15; 1.7 FL oz / 50 mL plastic bottles,
OTC facial moisturizer with Zinc Oxide 5.0% sunscreen. Made in U.S.A.; sold in
the following sizes: a) 1.7 FL oz / 50 mL plastic bottles, 6 per case, U.S.
label - sku 100-00256-000 (H70-131), UPC 7 64505 00256 2; Canada label - sku
300-00256-000, UPC 7 64505 00256 2; b) .27 FL oz / 8 mL plastic tube (sample),
350 tubes per case, sku 100-05256-000; The 1.7 FL oz bottles are also sold as a
component of the following kits: a) Sea Pure Tester Kit (Skincare - US -
English), sku 100-09994-000, UPC 7 64505 09994 4; b) Sea Pure Tester Kit
(Skincare - Canada - English), sku 100-09997-000, UPC 7 64505 09997 5; c) Sea
Pure Tester Kit (Skincare - Canada - French), sku 100-09996-000, UPC 7 64505
09996 8; d) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000.
CODE
Lot 090812A02; lot 090812A02; lot 090812A02
RECALLING FIRM/MANUFACTURER
H2O Plus, L.P., Chicago, IL,.
REASON
Error with Regard to Preservative: The lotion has the potential for preservative
failure, which would allow mold growth to occur.
VOLUME OF PRODUCT IN COMMERCE
8,653 1.7 fl oz bottles; 12,718 .27 fl oz tubes
DISTRIBUTION
Nationwide, Canada, Chile, Hong Kong, Malaysia and Mexico
WEEK ENDING MARCH 20
PRODUCT Sucralfate,
USP; CAS#54182-58-0, NDC: 055642-0011; Non-Sterile Bulk; Net Weight: 25 KG,
Gross Weight: 27.4 KG; For Manufacturing, Processing or Repacking; Rx
Only.
CODE
Batch Numbers: 20041002, 20041003, 20041004, 20071001, 20071002, 20071003,
20071004, 20071005, 20071006, 20071007, 20071008, 20071009, 20071010; 20071011,
20071012, 20071013, 20071014, 20071015, 20071026, 20071027, 20081001, 20081002,
20081004, 20081005, 20081006, 20081007, 20081008, 20081009, 20081010, 20081011,
20081012, 20081013, 20081014, 20081015, 20081016, 20081017, 20081018, 20081019,
20081020, 20081021, 20081022, 20081023, 20081024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flavine North America Inc., Closter, NJ
Manufacturer: Nanjing Pharmaceutical Factory Co., Ltd., Nanjing,
China.
REASON cGMP Deviations: An FDA inspection conducted September
21-25,2009 observed numerous violations in record keeping practices that are not
in accordance with the manufacturer's related SOPs and cGMP requirements, which
may cause the final product to be adulterated.
VOLUME OF PRODUCT IN COMMERCE 39068.8 KG
DISTRIBUTION FL, MN, MO, NJ, NY, PA, Croatia and Poland
PRODUCT BiCNU (carmustine)
for injection, 100 mg vial (NDC 0015-3012-18) and diluent, packaged in a kit (NDC
0015-3012-60), BMS Item number 301260; Rx only.
CODE Lot 8K4219A, Lot 1486494B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ,
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. REASON
Lack of Assurance of Sterility: Lack of assurance of sterility of one lot of
carmustine during retesting after importation through the European Union, to
Argentina.
VOLUME OF PRODUCT IN COMMERCE 2,570 kits in the United States;
International Unknown
DISTRIBUTION Nationwide, Argentina, Australia, Austria,
Bulgaria, Canada (packaged and sent from Indiana Technical Operations), Chile,
Columbia, Czech Rep, Ecuador, Finland, Hungary, Netherlands, Slovakia, Slovenia,
Spain, Sweden, Taiwan, Thailand, United Kingdom and Venezuela
PRODUCT Prednisone
Tablets, USP, 1 mg, Rx Only, 100 count (NDC 51991 458 01); 1000 count (NDC 51991
458 10) plastic bottles,
CODE Lot 8A064, Exp 2/10
RECALLING FIRM/MANUFACTURER
Cadista Pharmaceuticals, Inc., Salisbury, MD,
REASON Pharmaceutical failed to meet specification at 18 month
stability station.
VOLUME OF PRODUCT IN COMMERCE 4,668 bottles
DISTRIBUTION FL
PRODUCT Children's
Nasal Decongestant Liquid (Pseudoephedrine HCl), 30 mg, 4 FL oz (118 mL),
bottle; OTC; UPC Number N3 0536-1850-97 5.
CODE Lots 7D04, 7H04, 8C11 and 8F04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rugby Laboratories, Inc., Duluth, GA 2010.
Manufacturer: Bio-Pharm, Inc., Levittown, PA.
REASON Miscalibrated and/or defective delivery system. The
dosage cup provided with the product is not consistent with the dosing
instructions.
VOLUME OF PRODUCT IN COMMERCE 35,329 bottles
DISTRIBUTION Nationwide
PRODUCT Ranitidine
Tablets, USP, 150 mg, 500-count bottle, Rx only, NDC 53746-253-05. CODE
Lot HE14509, Exp. Date 6/2011
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Hauppauge, NY,
REASON Superpotent (Single Ingredient) Drug: This product is
being recalled because of two reports of oversized Ranitidine Tablets. Analysis
of a tablet showed 149% of label claim.
VOLUME OF PRODUCT IN COMMERCE 1965 bottles
DISTRIBUTION Nationwide
PRODUCT Our Family
Ibuprofen Caplets, Ibuprofen Tablets USP (NSAID) 200 mg, 24 Caplets, 200 mg
Each, NDC 70253-292-08, OTC. Item Number 1308-292-08, Product Code L-292.
CODE
Lots P56629 (exp. 4/30/2012), P57769 (exp. 6/30/2012), P53094 (exp. 9/30/2010),
P55188 (exp. 1/31/2011), P55779 (exp. 3/31/2011), P56537 (exp. 4/30/2012),
P56539 (exp. 4/30/2012), P59645 (exp. 9/30/2012) & P51376 (exp. 5/31/2010)
RECALLING FIRM/MANUFACTURER
LNK International, Inc., Hauppauge, NY,
REASON Mislabeling: the directions on the outer box are wrong
and lack the word "not", thereby incorrectly reading "Do exceed 6
caplets in 24 hours unless directed by a doctor".
VOLUME OF PRODUCT IN COMMERCE 32,144 bottles
DISTRIBUTION OH, SD
PRODUCT Claravis (isotretinoin)
USP, capsules, USP, 40 mg, 3 Prescription Blister Packs of 10 Capsules Each (30
capsules), Rx only; NDC 0555-1057-86.
CODE Lot number 312733 exp 7/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Barr Laboratories Inc., Pomona, NY.
REASON Some capsules do not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 5,770 boxes
DISTRIBUTION Nationwide
The Medicines Company Recalls Certain Lots of Cleviprex® That May Contain Particulate Matter
The Medicines Company (NASDAQ: MDCO) is recalling Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials. Four (4) additional lots of Cleviprex are being recalled. The four Cleviprex lots are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. The previously recalled lots were 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. T
Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor.
For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com.
WEEK ENDING MARCH 13
PRODUCT
LIBIPOWER PLUS Capsules, Natural Male Stimulant, 650 mg herbal blend, packaged
in 1 capsule blister packs.
CODE Lot Numbers: XHT890, Exp. 09/2010 & FIK531, Exp.
06/2011
RECALLING FIRM/MANUFACTURER
Haloteco, Santa Monica, CA
REASON Marketed without an approved NDA/ANDA: product found to
contain tadalafil which is the active ingredient of an FDA approved drug for
Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE Approximately 15,000 capsules
DISTRIBUTION CA
PRODUCT
Vicks Sinex Vapo Spray (Oxymetazoline HCl ) Nasal Spray 0.05%, 15 mL bottle,
OTC, UPC 3 23900 01253 0.
CODE Lot # 9239028831
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH,
Manufacturer: Procter & Gamble Gmbh & Co. Mfg. OHG, Gro-Gerau,
Germany
REASON Microbial Contamination of Non-Sterile Product: Product
may be contaminated with bacteria Burkholderia cepecia. A stability sample had
failed microbial content testing. The microbial content was 8560 cfu/ml for
total aerobic count (specification maximum is <100 cfu/ml).
VOLUME OF PRODUCT IN COMMERCE 44,352 bottles
DISTRIBUTION Nationwide, the United Kingdom, and Germany
PRODUCT Alka-Seltzer
Plus Day & Night Cold Formulas Liquid Gels is an OTC product. The
Alka-Seltzer Plus Day & Night Cold Formulas (combination pack only) contains
20 liquid filled capsules per carton (12 day formulation capsules and 8 night
formulation capsules) with NDC number is 0280-115--20, and the UPC number is
0-16500-53777-9. CODE Lot number 296939L (exp 5/2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ,
Manufacturer: Accucaps Industries Limited, Windsor, Ontario,
Canada.
REASON Labeling: Label Mix-Up: Firm is recalling one lot of
Alka Seltzer Plus Day & Night Cold Formulas Liquid Gels (combination pack
only) after identifying that the label on the foil blister card of certain
packages were printed with the label reversed. Therefore, the label for the
green Night product appears under some of the blue Day product and vice versa.
All individual liquid filled capsules are imprinted correctly
VOLUME OF PRODUCT IN COMMERCE 107,520 boxes
DISTRIBUTION Nationwide
PRODUCT
Allergy relief (diphenhydramine HCL) capsules, 25mg, 100-count bottle, OTC; NDC
11673-310-13; UPC 8 97882 00105 4; Allergy (Diphenhydramine Hydrochloride)
capsules, 25 mg, 24-count blisters in a box, OTC, NDC 65905-310-31, UPC 8 43072
00353 7 Multi-Symptom Complete Allergy (Diphenhydramine HCL) capsules, 25 mg,
24-count blisters in a box, OTC; UPC 8 97882 00109 2. The product was
distributed under the brand names Target, Diphendryl Allergy; Dollar General, DG
Allergy; and Today's Health, Today's Health Allergy. CODE Lot
number BK549
RECALLING FIRM/MANUFACTURER
Kirk Pharmaceuticals, LLC, Fort Lauderdale, FL,
REASON Temperature Abuse: Kirk Pharmaceuticals is recalling
Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to
improper storage conditions of the product during transit.
VOLUME OF PRODUCT IN COMMERCE 2,674,608 bottles and boxes
DISTRIBUTION Nationwide
PRODUCT
1) Intron A (Interferon alfa-2b, recombinant) Solution for Injection, 3 MIU
Multidose Pen, 6 doses of 3 million IU/0.2 mL per box, Rx only, NDC
0085-1242-01. Item number 21340707.
2) Intron A (Interferon alfa-2b, recombinant) Solution for Injection, 5 MIU Multidose Pen, 6 doses of 5 million IU/0.2 mL per box, Rx only, Product of Ireland, NDC 0085-1235-01. Item number: 21340405.
3) Intron A (Interferon alfa-2b,
recombinant) Solution for Injection, 10 MIU Multidose Pen, 6 doses of 10 million
IU/0.2 mL per box, Rx only. Product of Ireland, NDC 0085-1254-01. Item number
21341002.
CODE
1) Lot numbers 8-CO-2004, 9-CO-2001, 9-CO-2002, 9-CO-2003;
2) Lot numbers: 8-CO-1003, 8-CO-1004, 9-CO-1000, 9-CO-1001, 9-CO-1002, 9-CO-1003;
3) Lot numbers: 8-CO-3005, 9-CO-3000,
9-CO-3001, 9-CO-3002, 9-CO-3003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Corp., Kenilworth, NJ,
Manufacturer: Schering-Plough (Brinny) Co., County Cork, Ireland.
REASON Impurities/Degradation Products:Stability failure at 18
months detected impurities in Intron A (interferon alfa-2b, recombinant)
Solution in Multidose Pen for Injections.
VOLUME OF PRODUCT IN COMMERCE 64,240 boxes
DISTRIBUTION Nationwide
PRODUCT Humira (adalimumab)
Pen, for subcutaneous use only, 40 mg/0.8mL, 4 single-use prefilled pens (NDC
0074-4339-02) per Psoriasis Starter Package (NDC 0074-4339-07), UPC 3 00744
33907 8, Rx only.
CODE
Lot # 70266SP44, Exp SEP 2010; 74329SP41, Exp JAN 2011; 74329SP42, Exp JAN 2011;
and 74329SP45, Exp JAN 2011
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL,
REASON Unit Dose Mispackaging: Some of the Humira Psoriasis
Starter Packages may have been assembled in a configuration in which the
positions of the pens within the Starter Package carton were inconsistent with
the intended positions correlating to the recommended initial dosing regimen.
VOLUME OF PRODUCT IN COMMERCE 11,813 starter packages
DISTRIBUTION Nationwide, Bermuda, Cayman Islands
PRODUCT
1) Daytrana (methylphenidate transdermal system), CII, 20 mg (2.2 mg/hr), 30
count carton, Rx only, NDC 54092-554-30.
2) Daytrana (methylphenidate
transdermal system), CII, 30 mg (3.3 mg/hr), 30 count carton, Rx only, NDC
54092-555-30.
CODE
1) Lot #s: 33988, exp 12/31/10; 34174, exp 12/31/10; 34175, exp 12/31/10;
2) Lot #s: 33990, exp 12/31/10; 34179, exp 12/31/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire PLC, Wayne, PA,
Manufacturer: Noven Pharmaceuticals, Inc., Miami, FL. REASON
Miscalibrated and/or Defective Delivery System: no longer meets the release
liner removal specification.
VOLUME OF PRODUCT IN COMMERCE 25,886 cartons
DISTRIBUTION Nationwide
PRODUCT Dipyridamole
Tablets, USP 25 mg, a) 100 count bottles - NDC 0527-1461-01, and b) 1000 count
bottles, NDC 0527-1461-10; Rx Only;
CODE
Lot numbers: 2008261067 exp 6/2010 and 2008522883 exp 12/2010; b) Lot numbers:
2008261068 exp 6/2010 and 2008522884 exp 12/2010
RECALLING FIRM/MANUFACTURER
Lannett Co., Inc., Philadelphia, PA,
REASON Failed USP dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE 5,137 bottles
DISTRIBUTION Nationwide
PRODUCT Glyburide and
Metformin HCl, USP, tablets, 2.5 mg/500 mg, 1000 count bottles, Rx only, NDC
55111-696-10.
CODE Lot # 18007859, Exp. 4/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy's Laboratories Inc., Bridgewater, NJ, Manufacturer:
USV Limited, Dabhel, Daman, India.
REASON Adulterated Presence of Foreign Tablets: One batch of
Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg may have Glyburide
Metformin Hydrochloride 5 mg/500 mg tablets co-mingled in it.
VOLUME OF PRODUCT IN COMMERCE 685 bottles
DISTRIBUTION Nationwide
PRODUCT
1) Effexor XR (venlafaxine HCl) Extended Release capsules, 37.5 mg, a) 15-count
bottle, N DC 0008-0837-20; b) 30-count bottle, NDC 0008-0837-21; c) 90-count
bottle, NDC 0008-0837-22; Rx only.
2) Effexor XR (venlafaxine HCl) Extended-Release capsules, 75 mg, a) 15-count bottle (NDC 0008-0833-20); b) 30-count bottle (NDC 0008-0833-21); c) 90-count bottle (NDC 0008-0833-22); d) 100-count carton of 10 Redipak blister strips of 10 capsules each (NDC 0008-0833-03); Rx only.
3) Effexor XR (venlafaxine HCl)
Extended-Release capsules, 150 mg, a) 15-count bottle, NDC 0008-0836-20;
b) 30-count bottle, NDC 0008-0836-21; c) 90-count bottle, NDC 0008-0836-22; d)
100-count carton of 10 Redipak blister strips of 10 capsules each, NDC
0008-0836-03; Rx only. CODE
1) a) Lot Numbers C24657, C79353, C59181, Exp 10/10 -12/10; b) Lot Numbers
C30317, C87427, D44262, Exp 08/10 -10/11; c) Lot numbers C30329, C59182 ,C79360,
C98393, Exp 07/10-02/11;
2) a) Lot # C94009, C024262, Exp 03/11-07/11; b) Lot # C35138, C35139, C41328, C41329, C50306, C50307, C59523, C59524,C59526, C59530, C70592, C87937, C95682, C95699, D13622, D15930, D15931, D15932, D24603, D29149, Exp 08/11-10/11; c) Lot Numbers C40448, C40449, C40451, C46681, C46685. C46688, C46861, C51385S,C59184, C72564, C79438, C87911, C87912, C87913, C87914, D07619,D07620, D07621, D29150, D029151, D44256, D44259, D47414, D66746,D68004, D74751, D86901 Expiration Date 08/10 - 05/12; d) Lot Numbers D44210, D55950, Exp 10/10;
3) a) Lot Numbers C46773, C83940, Exp
8/10 and 12/10; b) Lot numbers C23201, C23205, C30294, C30298, C36097, C40978,
C41039, C41066, C46797, C46799, C59189, C79426, C79427, C87825, C87827, C87848,
C87853, C87859, C87860, D07625, D07626, D07627, D07629, D29069, D29153, D29154,
D29155, D34439, D37378, D37380, D88962, Exp 07/10-02/12; c) Lot Numbers C28511S,
C28512S, C28513S, C28514S, C28515S, C28517S, C36428S, C47303S, C47304S, C47305S,
C47306S, C47307S, C47308S, C51439S, C51440S, C5144IS, C51442S, C51443S, C51444S,
C70036S, C70037S, C70328S, C79627S, C79628S, C79629S, C79630S, C7963IS,
C79632S,C88186S, C88187S, C88188S, C88189S, C88190S, C88192S, C88193S, C88195S,
C95708S, C95862S, C95862S, C95863S, D03417S, D03422S, D03424S, D22794S,
D281165S, D28166S, D28197S, D29003S, D37029S, D65167S, D65170S, D65171S,
C95854S, C88194S, Exp 07/10-03/12; d) Lot Number C81860 Exp Date 01/11
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals Co., Guayama, PR,
REASON Cross Contamination With Other Products: Firm is
recalling Effexor extended release lots because of a potential
cross-contamination issue at one of their API suppliers.
VOLUME OF PRODUCT IN COMMERCE 10,554,952 bottles and cartons
DISTRIBUTION Nationwide
PRODUCT Zmax (azithromycin)
extended release for oral suspension, 2 g per bottle, packed in a box, Rx only,
NDC 0069-4170-21.
CODE Lot #17178VF, Exp 11/2011; Lot #V090373, Exp 11/2011; Lot
V090374, Exp 11/2011
RECALLING FIRM/MANUFACTURER
Pfizer Inc, New York, NY,
Manufacturer: Pfizer Pharmaceuticals LLC, Vega Baja, PR.
REASON Failed USP Dissolution Test Requirements: Zmax is being
recalled because it was determined that certain lots did not meet dissolution
specifications on stability.
VOLUME OF PRODUCT IN COMMERCE 67,872 bottles
DISTRIBUTION Nationwide
PRODUCT Clear Nicotine
(nicotine) Transdermal System patch, 7 mg delivered over 24 hours, 14-count
patches per box, OTC, Manufactured by: Aveva Drug Delivery Systems, Miramar, FL
33025; Rugby, UPC 3 0536-5894-88 3; equate, NDC 49035-894-88, UPC 6 81131 18741
1; equaline, NDC 41163-894-88, UPC 0 41163 45820 8; (Bulk Product) Nicotine
Transdermal System, 7 mg delivered over 24 hours, 1 patch per pouch, 4001080 is
packaged in 540-count pouches per box. Product was sold under Equate, Rugby, and
Equaline brands.
CODE Lot # 37264
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL,
REASON Impurities/Degradation Products: Product tested out of
specification for two degradants, myosmine and beta-nicotyrine.
VOLUME OF PRODUCT IN COMMERCE
384,384 patches (27,456 14-count boxes)
DISTRIBUTION Nationwide
PRODUCT
1) Clindamycin Injection, USP, (150 mg/mL) 300 mg/2 mL Single Dose Vial, Rx
only, Material Code 28202, NDC 63323-282-02.
2) Clindamycin Injection, USP, (150 mg/mL) 600 mg/4 mL Single Dose Vial, Rx only, Material Code 28204, NDC 63323-282-04.
3) Clindamycin Injection, USP, (150 mg/mL) 900 mg/6 mL Single Dose Vial, Rx only, Material Code 28206, NDC 63323-282-06.
4) Clindamycin Injection, USP, (150 mg/mL)
9 grams/60 mL vial, Pharmacy Bulk Package, Rx only, Material Code 28260, NDC
63323-282-60.
CODE
1) Lot# 405220; Exp 2/28/2010; Lot # 406688, Exp 12/31/2010; and Lot # 406689
Exp 12/31/2010;
2) Lot# 406127, Exp 8/31/2010; Lot# 406711, Exp 12/31/2010; and Lot# 406743, Exp 12/31/2010;
3) Lot# 406201, Exp 8/31/2010; Lot # 406712, Exp 12/31/2010; and 406744, Exp 12/31/2010;
4) Lot# 405174, Exp 02/28/2010; and Lot
# 406686, Exp 12/31/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL,
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY.
REASON Impurities/Degradation Products: This product is being
recalled because the lots have failed or have the potential to fail the Total
Impurities specification before expiration.
VOLUME OF PRODUCT IN COMMERCE 628,814 vials
DISTRIBUTION Nationwide
PRODUCT
1) Coats Aloe Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF
30+ Lotion provided Broad-Spectrum UVA and UVB Protection Untinted, 1 Liter; Lot
Number 05308G Coats Aloe Natural Sun Protection (titanium Dioxide 6%/zinc oxide
2.2%) SPF 30+ Lotion with UVA and UVB Protection, Color Free, 4 Fl oz Rhonda
Allison (titanium Dioxide 6%/zinc oxide 2.2%), SPF 30 SUNSCREEN, Color Free Sun
Protection, 1 Fl. oz.
2) Natural Sun Protection (titanium
Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion provided Broad-Spectrum UVA and UVB
Protection, 32 oz/946 mL; Lot Number 05308G Coats Aloe Int'l Natural Sun
Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion with UVA and UVB
Protection, 4 Fl oz Rhonda Allison (titanium Dioxide 6%/zinc oxide 2.2%), SPF 30
SUNSCREEN, Tinted Sun Protection, 1 Fl. oz. CODE
1) Lot number 05308G;
2) Lot numbers: 00308F, and 05508G
RECALLING FIRM/MANUFACTURER
Coats International Holdings, Inc., Dallas, TX,
REASON Product was distributed without proper stability data to
support the 2 year shelf-life.
VOLUME OF PRODUCT IN COMMERCE 8,170 tubes
DISTRIBUTION Nationwide
WEEK ENDING MARCH 6
PRODUCT Compro
prochlorperazine suppositories, USP 25 mg, NDC 0574-7226-12, for rectal use
Only, 12 adult suppositories, RX only.
CODE Lot No: 9116177 EXPANDED RECALL: Lot No. 8172830
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN,
REASON Paddock Laboratories, Inc. is conducting a voluntary
recall of Compro Prochlorperazine Suppositories, USP, 25 mg, due to the failing
dissolution at the 6-month stability time point. EXPANDED RECALL: Paddock has
expanded the recall to include lot 8172830 due to failing dissolution results.
Use of this product is unlikely to present a health risk
VOLUME OF PRODUCT IN COMMERCE
30,708 Expanded Recall: 12,720 units
DISTRIBUTION Nationwide
PRODUCT Amlodipine
Besylate and Benazepril HCl Capsules, 5mg/10mg (equivalent to amlodipine 5 mg
and benazepril 10 mg), Rx only, 1000 counts, Sandoz, NDC 0781-2272-10.
CODE Lot F1031 (exp. MARCH 2012)
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY,
REASON During sample preparation of Amlodipine Besylate &
Benazepril HCl 5 mg/10 mg combination product at the 6 month stability interval,
one capsule of lot F1031 did not contain the Benazepril 10 mg tablet.
VOLUME OF PRODUCT IN COMMERCE 1,910 units
DISTRIBUTION Nationwide
PRODUCT Allergy relief
(diphenhydramine HCL) capsules, 25mg, 100-count bottle, OTC; Distributed under
the brand names: 1) Target, NDC 11673-310-13, UPC 8 97882 00105 4; Allergy (Diphenhydramine
Hydrochloride) capsules, 25 mg, 24-count blisters in a box, OTC; Today's Health,
NDC 65905-310-31, UPC 8 43072 00353 7 Multi-Symptom Complete Allergy (Diphenhydramine
HCL) capsules, 25 mg, 24-count blisters in a box, OTC; UPC 8 97882 00109 2. The
product was distributed under the brand names Target, Diphendryl Allergy; Dollar
General, DG Allergy; and Today's Health, Today's Health Allergy.
CODE Lot number BK549
RECALLING FIRM/MANUFACTURER
Kirk Pharmaceuticals, LLC, Fort Lauderdale, FL,
REASON Temperature Abuse: Kirk Pharmaceuticals is recalling
Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to
improper storage conditions of the product during transit.
VOLUME OF PRODUCT IN COMMERCE
2,674,608 bottles and boxes
DISTRIBUTION Nationwide
PRODUCT Terazosin HCl
Capsules, 5 mg, 1000 count bottles, Rx Only; NDC 59746-385-10. CODE
Lot 9P050, exp 12/2010
RECALLING FIRM/MANUFACTURER
Cadista Pharmaceuticals, Inc., Salisbury, MD,
REASON Pharmaceutical may have been packaged with two dosage
strengths of the same drug.
VOLUME OF PRODUCT IN COMMERCE 2,626 bottles
DISTRIBUTION Nationwide
PRODUCT
1) Coats Aloe Vera Liniment (methyl salicylate) 10%, made from Whole Leaf Aloe
Vera Gel 1 oz., 8 fl. oz., 1 liter, OTC.
2) The Silent Healer by Coats Aloe Liniment Topical Analgesic, (methyl salicylate) 10%, 8 oz., 1 liter, OTC.
3) R Pur Aloe International (methyl
salicylate) Whole Leaf Aloe Vera Liniment, 10%, 8 oz. bottle, OTC, Made in
U.S.A.
CODE
1) Lot numbers: 05208g (exp. 08/2010), 03009C (exp. 03/2010), 3509C (exp
03/2010), 02309D (exp 04/2010), 09209F (exp. 7/2010), 05109G (exp 07/2010), and
07609G (exp 07/2010);
2) Lot #05208G (Exp. 08/2010);
3) Lot #09209F (Exp. 07/2010)
RECALLING FIRM/MANUFACTURER
Coats International Holdings, Inc., Dallas, TX,
REASON Sample product failed 6-month ambient test points for
assay of active ingredient.
VOLUME OF PRODUCT IN COMMERCE 30,511 units
DISTRIBUTION Nationwide