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U.S. Department of Health and Human Services

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Enforcement Report for May 2, 2007

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

May 2, 2007
07-18

 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
a) 1) Peter Pan™ brand Peanut Butter, Creamy, Net wt. 12oz (340g), 18oz (1 lb 2oz) 510g,
22oz (1 lb 6oz) 624g, 28oz (1 lb 12oz) 794g, 40oz (2 lbs 8oz) 2.23 kg, 56oz (3 lbs 8oz)
1.59 kg, 6 lb size (packed in laminate composite container). Retail size product is
packed in clear rigid plastic jars. Peter Pan brand Peanut Butter, Creamy is also
packed in .75 oz and 1.1 oz portion packs (packed in plastic tubs with cellophane lids).
These products are manufactured from 500 lb bulk creamy peanut butter,
2)Great Value™ brand Creamy Peanut butter, Net wt. 18oz (1 lb 2oz) 510g,
28oz (1 lb 12oz) 794g, and 40oz (2 lb 8oz) 1.13 kg. Product is packed in clear rigid
plastic jars.
3) (Spanish Label) Peter Pan™ Cema De Cacahuate, Cremosa, Cont. Net. 794g.
Product is packed in clear rigid plastic jars.
4) Peter Pan™ Creamy Peanut Butter, Net Weight 500 lb (226.8 kg), Ingredient #34570.
Code Date: 21116263, FRM 1566, Recall # F-198-7;
b) Crunchy peanut butter under the following labels: 1) Peter Pan™ brand Peanut Butter,
Crunchy, Net wt. 18oz (1 lb 2oz) 510g, 22oz (1 lb 6oz) 624g, 28oz (1 lb 12oz) 794g and
40oz (2 lbs 8oz) 1.13 kg.
2) Great Value™ brand, Crunchy Peanut Butter, Net wt. 18oz
(1 lb 2oz) 510g, 28oz (1 lb 12oz) 794g and 40oz (2 lb 8oz) 1.13kg. Product is packed in
clear rigid plastic jars, Recall # F-199-7;
c) Reduced fat creamy peanut butter under the following labels:
Peter Pan™ brand Peanut Butter Spread, Smart Choice, Reduced Fat, 25% Less
Fat Than Regular Peanut Butter, Creamy, Net Wt. 18oz (1 lb 2oz) 510g, Net wt. 28oz
(1 lb 12oz) 794g.
2) Great Value™ brand, Reduced Fat Peanut Butter Spread, 25% less fat than Peanut
Butter, Net Wt. 18oz (1 lb 2 oz) 510g. Product is packed in clear rigid plastic jars,
Recall # F-200-7;
d) Peter Pan™ band Peanut Butter Spread, Smart Choice, Reduced Fat, Crunchy,
Net Wt. 18oz (1 lb 2oz) 510g, Product is packed in clear rigid plastic jars. Recall # F-201-7;
e) Peter Pan™ PLUS Peanut Butter with 8 Essential Vitamins & Minerals, Creamy,
Net wt. 17.6oz (1 lb 1.6oz) 499g. Product is packed in clear rigid plastic jars, Recall # F-202-7;
f) Peter Pan™ PLUS Peanut Butter with 8 Essential Vitamins & Minerals, Crunchy,
Net wt. 17.6oz (1 lb 1.6oz) 499g. Product is packed in clear rigid plastic jars, Recall # F-203-7;
g) Peter Pan™ Peanut Butter & Natural Honey Spread, Creamy, Net Wt. 18oz (1 lb 2oz) 510g,
and 28oz (1 lb 12oz) 794g. Product is packed in clear rigid plastic jars. Recall # F-204-7;
h) Pan™ Peanut Butter & Natural Honey Spread, Crunchy, Net Wt. 18oz (1 lb 2oz) 510g,
and 28oz (1 lb 12oz) 794g. Product is packed in clear rigid plastic jars, Recall # F-205-7;
i) Peter Pan™ Peanut Spread, No Sugar Added, Creamy, Sweetened with Spenda®,
Net Wt 18oz (1 lb 2oz) 510g. Product is packed in clear rigid plastic jars, Recall # F-206-7;
j) Peter Pan™ Peanut Butter, Whipped, Creamy, Net wt. 14oz (397g).
Product is packed in clear rigid plastic jars, Recall # F-207-7
CODE
Product code ''2111'' printed primarily on the lid, however it can be found on any part of the plastic jar. The code has remained unchanged for domestic product. Production codes are the same and are inked on jar lids for both the Peter Pan and Great Value products. There is a slight variation in how the use by date is declared on Great Value products. Code breakdown is the same for both Peter Pan and Great Value and is located on the lid: 21115055 00 1037A. 2111 = Sylvester, GA plant, 5 = 2005, 055 = julian date, 1037 = military time, A = line. The 1 export product encountered thus far has a production date ''PRD 11/09/06'' followed by an expiration date ''11/09/08'' then ''ICOMTRADE.'' There are 5 export code variations. Export coding information will follow.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conagra Foods Inc., Omaha, NB, by press release on February 14, 2007 and by letter on/about February 15, 2007.
Manufacturer: ConAgra Grocery Products, Sylvester, GA. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
326,000,000 lbs.
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Dramamine Less Drowsy Formula (Meclizine hydrochloride), 25 mg Tablets, packaged in 8 count vials and double count value pack, Single pack NDC 0501-6201-08, Double pack NDC 0501-6201-16, Recall # D-784-2007
CODE
Lot numbers 81948 exp 12/31/09, and 84515 exp 12/31/09. Lot number 87295 exp 8/31/10 (value pack)
RECALLING FIRM/MANUFACTURER
McNeil Consumers Healthcare, Division of McNeil-PPC, Inc, Fort Washington, PA, by letter dated April 4, 2007. Firm initiated recall is ongoing.
REASON
Labeling; immediate container label incorrectly states dosing at 1-2 tablets every 4 to 6 hours not to exceed 8 tablets in 24 hours. Label should state dosing at 1-2 tablets daily or as directed by a doctor.
VOLUME OF PRODUCT IN COMMERCE
549,798 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0778-07;
b) Platelets, Recall # B-0779-07
CODE
a) and b) Unit: 1311546
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated November 25, 2005. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Fresh Frozen Plasma that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-0939-07
CODE
Units: LL51286 Parts 1 and 2
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island Blood Center, Providence, RI, by telephone and follow-up letter on January 29, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI

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PRODUCT
Source Plasma, Recall # B-0943-2007
CODE
Units: 0370556400, 037055087, 0370552987, 0370551370, 0370550702, 0370548789, 0370548635
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Medford, OR, by fax on November 11, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was allowed to donate without having a current physical, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Platelets Pooled Irradiated, Recall # B-0946-07
CODE
Unit: G153162
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated January 14, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was raped within one year of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0947-07;
b) Platelets Leukocytes Reduced, Recall # B-0948-07
CODE
a) Units: LH48368, LH56518;
b) Unit: LH56518
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island blood Center, Providence, RI, by telephone and follow-up letter on January 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MA and RI

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PRODUCT
Red Blood Cells, Deglycerolized, Leukocytes Reduced, Recall # B-1213-07
CODE
Unit: 6935943
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on April 3, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-1214-07
CODE
Units: LG43813 (Parts 1 and 2), LG39223 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island blood Center, Providence, RI, by telephone and follow-up letter on January 29, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MA and NY

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PRODUCT
Red Blood Cells, Recall # B-1218-07
CODE
Unit: 5166176
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on June 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of jaundice with mononucleosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1221-07
CODE
Unit: 7113661
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1222-07;
b) Recovered Plasma, Recall # B-1223-07
CODE
a) and b) Units: 5587539, 9710079
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and e-mail beginning August 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA and Switzerland

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1224-07
CODE
Units: 5596525, 7118022 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated July 13, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AK

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1225-07;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1226-07
CODE
a) Units: 4043599, 4040278;
b) Unit: 5787935
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated May 31, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AK and LA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1232-07
CODE
Unit: LM30535
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on December 8, 2006 and by e-mail on December 12, 2006. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI

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PRODUCT
Source Plasma, Recall # B-1233-07
CODE
Units: 05BMTB6418, 05BMTB7000
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, Deerfield, IL, by facsimile on June 29, 2005.
Manufacturer: BioLife Plasma Services, Billings, MT. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post-donation information regarding a history of brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1210-07;
b) Fresh Frozen Plasma, Recall # B-1211-07
CODE
a) and b) Unit: 71N46567X
RECALLING FIRM/MANUFACTURER
Recalling Firm: Life South Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 14, 2005.
Manufacturer: Life South Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood products, collected from a therapeutic donor with a history of Polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1219-07
CODE
Units: 04P62296 (2 units), 04GP65572, 04GP65569, 04GP65570
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated January 3, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Pheresis, Leukocytes Reduced, Recall # B-1227-07
CODE
Units: 027LQ26912, 027LQ26913
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on August 23, 2006 and by letter dated August 24, 2006. Firm initiated recall is complete.
REASON
Blood products, which were unlicensed, but were labeled as licensed products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Prosthetic Knee Joint (for external prosthesis, not implant), Recall # Z-0759-2007
CODE
Serial numbers 22509, 24208, 2326D, 2334C, 2337F, 2339H, 2341A 2342B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medi Manufacturing Inc., Whitsett, NC, by telephone and letter on August 11, 2006.
Manufacturer: Medi Bayreuth, Bayreuth, Germany. Firm initiated recall is complete.
REASON
Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide

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PRODUCT
Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha characters which specify option and language packs), Recall # Z-0760-2007
CODE
Serial Numbers: 0619450019 0619450065 0619450072 0619450136 0619450214 0619450387 0619450402 0619460020 0620450072 0620450211 0620450224 0621450055 0621450106 0621450152 0623450106 0624450025 0626450123 0626450144 0626450198 0626450201 0626450229 0626450236 0626450291 0626450344 0626450358 0626450363 0626450394 0626450429 0630450051 0632450125 0632450258 0632450259 0632450315 0632450318 0633450095 0639450015 0639450038 0639450040 0639450052 0639450091 0641450052 0641450061 0641450300 0641450325 0647450012 0647450036 0647450052 0647450169 0647450265 3510060688 3510060784 3510062230 3510062231 3510062250 3510062263 3510062265 3510062272 3510062281 3510062294 3510062295 3510062300 3510062302 3510062304 3510062307 3510062309 3510062311 3510062313 3510062315 3510062318 3510062358 3510062359 3510062360 3510062361 3510062362 3510062363 3510062364 3510062365 3510062366 3510062367 3510062368 3510062369 3510062370 3510062371 3510062372 3510062373 3510062374 3510062375 3510062376 3510062377 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RECALLING FIRM/MANUFACTURER
Recalling Firm: Nellcor Puritan Bennett, Pleasanton, CA, by letter or personal contact beginning on March 12, 2007.
Manufacturer: Puritan Bennett Ltd., Mervue, Ireland. Firm initiated recall is ongoing.
REASON
In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.
VOLUME OF PRODUCT IN COMMERCE
3,756 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007
CODE
Model 3500 pump with 4.1.4 or 4.1.3 software.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by a 'Customer Information Bulletin' dated February 3, 2007 and a 'Product Recall Notification' dated February 16, 2007.
Manufacturer: Medex Inc, Duluth, GA. Firm initiated recall is ongoing.
REASON
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.
VOLUME OF PRODUCT IN COMMERCE
23,519 units
DISTRIBUTION
Nationwide, Canada and Italy

___________________________________
PRODUCT
Magnetom Espree System with OR Table, Model number 10092082, Recall # Z-0769-2007
CODE
Serial number 1002, 1003, and 1004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 30, 2007.
Manufacturer: Siemens AG MED, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
If table top is not seated properly it can lock up/stick.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY and TX

END OF ENFORCEMENT REPORT FOR MAY 2, 2007

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