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Author Topic: RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II 09/09/2009  (Read 1874 times)
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JustMe
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« on: September 09, 2009, 02:35:59 PM »

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm181754.htm

This is on the Enforcement Report for September 9, 2009.  Not sure if this is new or ongoing.


RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
AmTech Group Inc. Gentamicin Sulfate Pig Pump Oral Solution, packaged in a 4-fl. oz. bottle, each ml contains gentamicin sulfate equivalent to 5 mg gentamicin, RX, ANADA 200-174, NDC 59130-663-07. Recall # V-259-2009
CODE
Lot #8080589, Exp. 11-2010
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters dated May 14, 2009. Firm initiated recall is ongoing.
REASON
Stability failure - The product did not meet assay or preservative specifications.
VOLUME OF PRODUCT IN COMMERCE
3,812/4-fl. oz. bottles
DISTRIBUTION
MO, CO, and NC
___________________________________
PRODUCT
1) Levothyroxine Sodium Tablets 0.2 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.2 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.2 mg, Recall # V-260-2009;

2) Levothyroxine Sodium Tablets 0.5 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.5 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.5 mg, Recall # V-261-2009;

3) Levothyroxine Sodium Tablets 0.8 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.8 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.8 mg, Recall # V-262-2009;

4) Phenylbutazone Tablets, 1 g., packaged in 100-tablet bottles, RX, under the following labels: (1) A & G Pharmaceuticals Phenylbutazone Tablets, USP; (2) Pro Labs Pro-Bute Tablets; (3) Butler ButaTabs E; (4) AmTech Group Inc. Phenylbutazone Tablets, USP; (5) Phoenix Pharmaceutical Inc. Phenylbute Tablets; (6) VetTek Phenylbutazone Tablets; (7) VEDCO Bute Tabs; and (Cool RXV Phenylbutazone Tablets, USP, Recall # V-263-2009;

5) Phenylbutazone Tablets, 100 mg, packaged in 1,000-tab. bottles, RX, under the following labels: (1) Butler ButaTabs D; and (2) AmTech Group, Inc. Phenylbutazone Tablets, USP, Recall # V-264-2009;

6) Praziquantel Tablets, 34 mg, RX, packaged under the following labels: (1) Trade Winds Tape Worm Tabs, packaged in 5-tab. bottles; (2) Farnam D-Worm Praziquantel Tablets, packaged in 5- and 10-tab. bottles; (3) Phoenix Pharmaceutical Inc. CestaTabs, packaged in 50- and 150-tab. bottles; (4) VEDCO Cestoved Tablets, packaged in 50- and 150-tab. bottles; (5) Butler Prazitabs D, packaged in 50- and 150-tab. bottles; and (6) AmTech Group Inc. Praziquantel Tablets, packaged in 50- and 150-tab. bottles, Recall # V-265-2009;

7) Clindamycin Hydrochloride Capsules, 25 mg, packaged in 600-cap. bottles, RX, under the following labels: (1) Butler Clincaps 25; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-266-2009;

Cool Clindamycin Hydrochloride Capsules, 75 mg, packaged in 200-cap. bottles, RX, under the following labels: (1) Butler Clincaps 75; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-267-2009;

9) Clindamycin Hydrochloride Capsules, 150 mg, packaged in 100-cap. bo9ttles, RX, under the following labels: (1) Butler Clincaps 150; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-268-2009;

10) Clindamycin Hydrochloride Capsules, 300 mg, packaged in 100-cap. bottles, RX, under the following labels: (1) Butler Clincaps 300; (2) VEDCO ClindaCure; and (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules, Recall # V-269-2009
CODE
1) 180 ct. – Lot numbers: 8020127 and 8050365; 1,000-ct. - Lots 7071016, 7071017, 7101394, 7101395, 8010055, 8020128, 8030254, 8070482, 8070483, 8080551, and 8080552;

2) 180-ct. – Lot numbers: 8050366 and7081165; 1,000-ct. - Lots 7101396, 7101397, 7111484, 7111485, 8020129, 8020130, 8030211, 8030212, 8070484, and 8070485;

3) 180-ct. – Lot numbers: 7050762, 7111488, 8040300, and 8080553; 1,000-ct. - Lots 7040661, 7040662, 7040663, 7101398, 7101399, 7101400, 7101401, 7111486, 7111487, 8010042, 8010043, 8020131, 8020132, 8020133, 8030221, 8030222, 8030223, 8040300, 8040301, 8040302, 8040303, 8070486, and 8070487;

4) Lot numbers: 7081167, 7081168, 7101409, 7101410, 7101446, 7111480, 7111481, 7111482, 7121563, 7121564, 8020166, 8030225, 8030272, 8030273, 8040304, 8040305, 8050367, 8070477, 8070478, 8080554, 8080555, 8090611, 8090612, 8090613, 8100686, 8100687, 8110786, and 9010019;

5) Lot numbers: 7060905, 7111483, 8060462, and 8100756;

6) Lot numbers: 7050776 (150-ct.), 7050781 (10- and 150-ct.), 7060920 (5- and 10-ct.), 7081161 (50-ct.), 7101411 (5- and 10-ct.), 7101441 (150-ct.), 7111498 (5-ct.), 7121598 (50-ct.), 7121599 (150-ct.), 8020155 (5- and 10-ct.), 8020156 (5- and 10-ct.), 8030224 (150-ct.), 8060414 (10-ct.), 8060415 (5- and 10-ct.), 8060445 (5-ct.), 8060446 (50-ct.), 8080550 (5- and 10-ct.), 8090609 (50-ct.), 8090610 (150-ct.), 8100685 (10- and 150-ct.), 8110785 (5- and 10-ct.), 9010018 (50-ct.), and 9020094 (150-ct.);

7) Lot numbers: 7050763, 7050764, 7071012, 7081157, 7101389, 7111489, 8010001, 8010002, 8020165, 8030219, 8040338, 8070479, 8070480, 8080556, 8080557, 9010020, and 9010068;

Cool Lot numbers: 7050761, 7071013, 7081160, 8010044, 8030220, 8040306, 8070481, 8120869, 9010021, and 9010022;

9) Lot numbers: 7101390, 7101440, and 8090614;

10) Lot numbers: 7071014 and 8080558
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters between May 1, 2009-May 7, 2009. Firm initiated recall is ongoing.
REASON
Some of the tablets have physical characteristic defects.
VOLUME OF PRODUCT IN COMMERCE
216,690/5-ct, 125,430/10-ct, 18,498/50-ct, 105,137/100-ct, 10,617/150-ct., 22,145/180-ct, 35,417/200-ct., 18,250/600-ct, and 25,527/1,000-ct
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR SEPTEMBER 9, 2009
« Last Edit: September 09, 2009, 02:48:42 PM by JustMe » Logged

Eventually they will understand,
Replied the glorious cat
For I will whisper into their hearts
That I am always with them
I just am....forever and ever and ever.
Poem for Cats, author unknown

"A kitten in the animal kingdom is like a rosebud in a garden", author unknown
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