FEBRUARY 2008
WEEK ENDING FEBRUARY 2
NuCel Labs Eye Drops and Eye/Ear Wash Products
NuCel Labs of Idaho Falls, Idaho is recalling all Eye Drops and Eye/Ear Wash. Product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile.
Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled "Eye Drops Caution: Do Not Use With Implants" or "Eye/Ear Wash" are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.
Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full refund.
Consumers with questions may call NuCel Lab at 208-542-0325.
PRODUCT a)
Perphenazine Tablets, USP, 8 mg, 100 and 500 tablets, Rx only, NDC 0603-5092-21 and NDC 0603-5092-28, NDC 54738-552-01,
b) Perphenazine Tablets,
USP, 16 mg, 100 tablets, Rx only, NDC
0603-5093-21 and NDC 54738-553-01,
CODE
a) 100 count: T019G07D, exp 07/09 and
T019G07C, exp 07/09;
500 count: T019G07B, exp 07/09 and
T019G07A, exp 07/09;
b) 100 count: T049F07A, exp 06/09; T020G07B, exp 07/09;
and, T020G07A, exp 07/09
RECALLING
FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL
REASON Tablet separation; cracking and splitting of
tablets.
VOLUME OF PRODUCT IN COMMERCE 20,402 units
DISTRIBUTION Nationwide
PRODUCT
a) Children's Dimetapp Cold & Chest Congestion Syrup, active
ingredients (in each 5 mL tsp): Phenylephrine HCl 5 mg
and Guaifenesin 100 mg, 4 fl. oz. bottles, OTC,
b) Robitussin Cough & Cold CF Syrup, active ingredients (in
each 5 mL tsp): Dextromethorphan HBr 10 mg, Guaifenesin
100 mg, Phenylephrine HCl 5 mg; 4 fl. oz., 8 fl. oz. and
12 fl. oz. bottles, OTC,
c) Robitussin Cough &
Congestion Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg and Guaifenesin 200 mg; 4 fl. oz. and 8 fl. oz.
bottles, OTC,
d) Robitussin Cough
DM Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg and Guaifenesin 100 mg; 4 fl. oz., 8 fl. oz, and 12 fl. oz. bottles, OTC,
e)
Robitussin-CF Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg; Guaifenesin 100 mg, Pseudoephedrine HCl 30 mg; 4
fl. oz., 8 fl. oz., and 12 fl. oz. bottles, OTC,
f) Robitussin PE Syrup, active ingredients (in each 5 mL tsp):
Pseudoephedrine HCl 30 mg and Guaifenesin 100 mg; 4 fl.
oz. and 8 fl. oz. bottles, OTC,
g) Robitussin Head & Chest Congestion PE Syrup, active ingredients
(in each 5 mL tsp): Phenylephrine HCl 5mg and Guaifenesin
100 mg; 4 fl. oz. bottles, OTC,
h) Robitussin Sugar Free Cough Syrup, active ingredients (in each
5 mL tsp): Dextromethorphan HBr 10 mg and Guaifenesin 100
mg; 4 fl. oz. bottles, OTC,
CODE
a) All lots with expiration date May
2009;
b) All lots with expiration dates January 2008 to August 2009;
c)
All lots with expiration dates May 2008 to August 2010;
d) All lots with
expiration dates October 2007 to August 2010;
e) and f) All lots within
expiration;
g) All lots with expiration dates January 2008 to April
2009;
h) All lots with expiration dates October 2007 to February
2010
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond,
VA
REASON Dosing cups packaged with the product lack the
1/2 teaspoon mark for dosing children 2 to 6 yrs of age.
VOLUME OF
PRODUCT IN COMMERCE 1,822,132 bottles/month
DISTRIBUTION
Nationwide
PRODUCT Lithium
Carbonate Extended Release Tablets, USP, 450 mg, 90 and100 count bottles, Rx
only, NDC 0143-1277-01,
CODE 100
count bottle; Lot number 62395C, Exp. Date 3/2008,
90 count bottle; Lot
number 62395B, Exp. Date 3/2008
RECALLING
FIRM/MANUFACTURER West-Ward Pharmaceutical Corp, Eatontown, NJ,
REASON
Failed USP Dissolution Specification; 18
month stability.
VOLUME OF PRODUCT IN COMMERCE 156
bottles of 100 count.
DISTRIBUTION Nationwide and
PR
PRODUCT Budeprion
SR (Bupropion HCl) Extended-Release Tablets, 150 mg, 100-tablet bottles, Rx
only, NDC 0093-5502-01,
CODE Lots:
7050091, 7050101, 7050961, 7050971, 7050981, 7050991, 7051001, 7051011, 7051021,
7051031, 7051041, 7051051, 7051061, 7051071, 7051081, 7051091; expiry 5/2009 for
all lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva
Pharmaceuticals USA, North Wales, PA,
Manufacturer: Impax Laboratories Inc, Hayward, CA.
REASON
Product does not meet
time-release dissolution specifications.
VOLUME OF PRODUCT IN
COMMERCE 187,455/100-tablet
bottles
DISTRIBUTION Nationwide
PRODUCT Robitussin Chest Congestion Guaifenesin Syrup, active ingredient
(in each 5 mL tsp): Guaifenesin 100 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC,
CODE
All lots with expiration dates
October 2007 to August 2010
RECALLING
FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA
REASON
Dosing cups packaged
with the product lack the 1/2 teaspoon mark for dosing children 2 to 6 yrs of
age.
VOLUME OF PRODUCT IN COMMERCE 1,822,132
bottles/month (D-087-2008 – D-295-08 are Class II and volume is
included in this figure)
DISTRIBUTION Nationwide
WEEK ENDING FEBRUARY 9
PRODUCT Simvastatin Tablets
USP, 20 mg, 1,000-tablet
bottle, Rx only, NDC 0093-7154-10,
CODE Lot 02S179, exp
8/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva
Pharmaceuticals USA, North Wales, PA,
Manufacturer: Teva Pharmaceutical Industries, Har
Hozvim, Jerusalem,
Israel.
REASON Product
may contain some Carvedilol 25 mg tablets.
VOLUME OF PRODUCT IN
COMMERCE 1,447 bottles/1,000-tablet
bottles
DISTRIBUTION IL, NJ, and NV
PRODUCT IVAX
Aspirin Tablets, 81 mg, enteric coated, 100-tablet unit dose package, OTC, NDC
0182-8217-89,
CODE Lot
067210
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Amerisource Health Services Corp, Columbus, OH,
Manufacturer: Time-Cap Labs, Farmingdale, NY.
REASON
Product fails assay and impurity
specifications.
VOLUME OF PRODUCT IN
COMMERCE 11/100-unit dose
packages
DISTRIBUTION GA
WEEK ENDING FEBRUARY 16
PRODUCT
1)
Non-Aspirin Pain Reliever/Fever Reducer, Acetaminophen, 325 mg,
2) Maximum Strength Nasal Decongestant PE,
Phenylephrine Hydrochloride 10 mg,
3) Nasal Decongestant, Pseudoephedrine Hydrochloride, 30 mg,
4) Nasal Decongestant/Antihistamine, Pseudoephedrine
Hydrochloride 60 mg and Triprolidine Hydrochloride 2.5
mg,
5) Antihistamine, Chlorpheniramine Maleate, 4 mg,
100 TABLETS,
6) Extra Strength
Non-Aspirin Gelatin Tablets, Acetaminophen, 325 mg,
7) Extra Strength Non-Aspirin Gelatin Tablets,
Acetaminophen 500 mg,
8) Aspirin
Free Headache PM, Acetaminophen 500mg and Diphenhydramine
Citrate 38 mg,
9) Aspirin Pain
Reliever/Fever Reducer, 325 mg,
10) Aspirin, (Enteric
Coated)/Pain Reliever/Fever Reducer, 325 mg,
11) Allergy Medication, Diphenhydramine Hydrochloride 25 mg,
12) Pain Reliever/Fever Reducer
(NSAID), Ibuprofen USP,
200 mg,
13) Stool Softener,
Docusate Sodium 100 mg, ;
14) Nighttime Sleep-Aid,
Diphenhydramine Hydrochloride 25 mg,
15) Maximum Strength Nighttime Sleep-Aid, Diphenhydramine
Hydrochloride USP 50 mg,
16)
Extra Strength Non-Aspirin PM, Acetaminophen 500 mg,
17)
Low Strength Aspirin Regimen Enteric Coated, Aspirin 81 mg,
18)
Anti-Diarrheal, Loperamide HCl Tablets USP, 2 mg,
19) Day-Time Cold/Flu Medicine
Softgels, Pseudoephedrine
Hydrochloride 30 mg, Acetaminophen 250 mg,
Dextromethorphan Hydrobromide 10 mg,
20) Night-Time Cold/Flu Medicine
Softgels, Doxylamine Succinate,
6.25mg, Dextromethorphan Hydrobromide, 10 mg,
Acetaminophen 250 mg, and Pseudoephedrine
Hydrochloride 30 mg,
21) Fiber Laxative Caplets, Calcium
Polycarbophil 625 mg equivalent to 500 mg
polycarbophil, Bulk-forming laxative,
22)
Multi-Symptom PMS Caplets, Premenstrual Symptom Reliever, Acetaminophen 500 mg, Pamabrom 25 mg, Pyrilamine Maleate 15 mg,
23) Natural Laxative Tablets (Standardized Senna
Concentrate), Sennosides 8.6 mg,
24) Pain Reliever/Fever Reducer (NSAID), Naproxen sodium 220 mg,
25) Antacid Tablets/Calcium
Supplement, Assorted Fruit Flavors, Naturally and
Artificially Flavored, Manufactured and distributed in the following
dosages: Calcium Carbonate USP 750 mg, Antacid *
Calcium Carbonate USP 500 mg, Antacid * Calcium
Carbonate USP 1000 mg,
26) Chocolated Stimulant
Laxative, Sennosides USP, 15 mg,
27) Women's Laxative
Tablets, Bisacodyl 5 mg, Stimulant laxative.
28) Cimetidine Tablets, USP, 200 mg, Acid reducer,
29) Acid Reducer, Ranitidine Tablets
USP, 75 mg (as ranitidine
hydrochloride USP 84 mg), ;
30) Extra Strength, Non-Aspirin PM, Gelcaps, Acetaminophen 500
mg, and Diphenhydramine, Hydrochloride 25 mg, Pain
reliever/Fever reducer and Sleep aid,
31) Allergy Medication Decongestant Capsule-Shaped Tablets,
Diphenhydramine Hydrochloride 25 mg,
Pseudoephedrine Hydrochloride 60 mg, Antihistamine/ Nasal Decongestant,
32)
Acid Reducer, Famotidine Tablets USP, 10 mg,
33) Extra
Strength Non-Aspirin Allergy Sinus Gelatin Caplets, Acetaminophen 500 mg, Chlorpheniramine maleate 2 mg, and
Pseudoephedrine HCl 30 mg, Pain reliever/
Antihistamine Nasal decongestant,
34) Ibuprofen Liquid Softgels, Ibuprofen 200 mg, Pain reliever/fever reducer,
35) Ibuprofen
Capsules, Ibuprofen 200 mg (NSAID), Pain reliever/fever reducer,
36) Non Drowsy*
Allergy Relief, Loratadine 10 mg Tablets, Antihistamine,
37) Psyllium Fiber Capsules, 100% Natural
Psyllium husk approximately 520 mg, Bulk
forming laxative, Fiber Therapy for Regularity / Fiber Supplement,
38) Non-Drowsy
24-Hour ALLERGY & CONGESTION RELIEF Extended
Release Tablets, Loratadine 10 mg and
Pseudoephedrine sulfate 240 mg, Antihistamine/ Nasal
decongestant,
39) Antihistamine Nasal
Decongestant, Chlorpheniramine maleate 4 mg and Phenylephrine HCl 10 mg,
40) MAXIMUM STRENGTH, SINUS HEADACHE PE, Acetaminophen 325 mg
and Phenylephrine HCl 5 mg, Pain
Reliever/Nasal Decongestant,
41) Cough Suppressant,
Dextromethorphan HBr, 15 mg,
42) Cough Suppressant,
Dextromethorphan HBr, 7.5 mg,
43) Children's Cough, Cold
& Allergy Strips, Diphenhydramine Citrate 19 mg, Cough Suppressant/Antihistamine,
44) Children's Cough & Runny Nose, Diphenhydramine citrate 19
mg, Cough Suppressant/Antihistamine,
Manufactured and distributed under the following Brand names: Meijer, Raspberry
Flavored Medicated
Strips,
45) Children's Allergy, Diphenhydramine citrate
19 mg, Antihistamine, 46) Pain Reliever/Fever Reducer/Nasal Decongestant, Ibuprofen 200 mg
(NSAID) and Pseudoephedrine HCl 30 mg,
nonsteroidal anti-inflammatory drug,
47) Pain Reliever/Nasal
Decongestant, Acetaminophen 325 mg, Phenylephrine HCl 5 mg,
48) Pain
Reliever/Fever Reducer, Antihistamine/Cough Suppressant, Nasal Decongestant, Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg, Phenylephrine
HCl 5 mg,
49) Cough & Cold, Antihistamine/Cough
Suppressant, Decongestant-Free, For People
with High Blood Pressure, Chlorpheniramine maleate 4 mg, Dextromethorphan HBr 30 mg,
50) Maximum
Strength Menstrual Formula Caplets, Acetaminophen 500 mg, Caffeine 60 mg, Pyrilamine maleate 15 mg,
51) Pain Reliever, Antihistamine, Nasal Decongestant,
Acetaminophen 325 mg, Diphenhydramine HCl
12.5 mg, Phenylephrine HCl 5 mg, 52) Daytime Cold/Flu PE Softgels, Multi-Symptom COLD/FLU Relief, Acetaminophen 325 mg, Dextromethorphan HBr 10 mg,
Phenylephrine HCl 5 mg,
53) Nighttime Cold & Flu Softgels Multi-Symptom COLD/FLU Relief,
Acetaminophen 325 mg, Dextromethorphan HBr 15
mg, Doxylamine Succinate 6.25 mg,
54) Extra Strength Acetaminophen 500 mg, Easy To Swallow Tabs, Pain
reliever/fever reducer, ;
55) Maximum Strength, Famotidine Tablets, USP 20 mg,
56) Alertness Aid with Caffeine, Caffeine, 200 mg,
57) Backache Relief, Magnesium
Salicylate, 467.2mg,
58) Antacid, Gelatin Caplets, Calcium carbonate, 550mg, Magnesium
hydroxide, 125mg,
CODE All distributed OTC drug products that
are still within expiration dating.
RECALLING
FIRM/MANUFACTURER Leiner Health Products, Llc,r Nw, Wilson, NC,
REASON cGMP Deficiencies
VOLUME OF PRODUCT IN
COMMERCE 148,836,257 units
total
DISTRIBUTION Nationwide and Canada
WEEK ENDING FEBRUARY 23
Actavis Recalls Certain Fentanyl Patches in the US
Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being recalled from wholesalers and pharmacies as a precaution.
The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.
Fentanyl patches sold by Actavis in Europe are not affected by this recall.
The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.
The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.
Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis
Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl
Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal
System, 100 mcg/hr. NDC 67767-123-18.
Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.
Affected patches should not be handled directly.
Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452.
Patients using fentanyl patches who have medical questions should contact their health-care providers.