CODE
Retail packages are coded with "For best results use before"
dates of "NOV 18 J" and "NOV 18 K." Cases are coded "NOV 18."
MANUFACTURER
The Pillsbury Company, Denison, Texas.
RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by electronic mail
and by press release on September 8, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,824 cases (12 18-ounce packages per case) were distributed.
REASON
Product contains undeclared walnuts.
CODE
Lot numbers: ADM7 EXP 11/30/98, AH36 EXP 5/31/99, AH9D EXP
8/31/99.
MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.
RECALLED BY
Manufacturer, by letter dated September 1, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
5,972 units were distributed; FDA estimates very little, if any
product remains on the market.
REASON
Contamination - Some units may contain particles from the lining
(glass) of a manufacturing vessel.
PRODUCT
Compressed Medical Oxygen, USP, in D, E, and M-6 aluminum and
steel cylinders. Recall #D-002-9.
CODE
All lot codes.
MANUFACTURER
Omega Medical Equipment, Inc., doing business as Mountain Air
Services, Pennington Gap, Virginia.
RECALLED BY
Manufacturer, by visit on September 23, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Virginia, Kentucky, Tennessee.
QUANTITY
Firm estimated that less than 50 cylinders remained on market at
time of recall initiation.
REASON
Current Good Manufacturing Practice deviations, including but not
limited to failure to assay for potency.
UPDATE
Inwood Laboratories, Inc. (Inwood, New York),
Recall #D-100/103-8 which appeared in the March 15,
1998, April 1 and 15, 1998, July 29, 1998, August 26,
1998, September 23, 1998 Enforcement Reports has been
extended as follows:
Propranolol HCl 60 mg Extended Release (ER) Capsules, 100 count
bottles, Lots 7F047, 7H003, 7K017, 8A043.
Propranolol HCl 80 mg ER Capsules, 100 count bottles, Lot 7F049.
Propranolol HCl 120 mg ER Capsules, 100 count bottles, None.
Propranolol HCl 160 mg ER capsules, 100 count bottles, Lot
7F062.
CODE
Lot #88760 EXP 6/99.
MANUFACTURER
Leiner Health Products, Garden Grove, California.
RECALLED BY
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter dated
September 30, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
47,930 cartons were distributed.
REASON
Subpotency - Riboflavin and Thiamine Mononitrate.
CODE
Unit numbers: TR-16271, TR-16276, TR-16021, TR-16095, TR-16102,
TR-16124, TR-16132, TR-16176, TR-16179, TR-13871, TR-13913,
TR-14494, TR-14774, TR-15068, TR-15277, TR-15664, TR-15670.
MANUFACTURER
Trimar Hollywood, Inc., Reseda, California.
RECALLED BY
Manufacturer, by letter dated August 7, 1998. Firm-initiated
recall complete.
DISTRIBUTION
California and Texas.
QUANTITY
17 units were distributed.
REASON
Blood products tested negative for the antibody to the human
immunodeficiency virus (HIV-1/2), but were collected from a donor
who on several occasions had previously tested repeatedly
reactive for the antibody, Western Blot Indeterminate or
negative.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-015/016-9.
CODE
Unit #C02749.
MANUFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame,
California.
RECALLED BY
Manufacturer, by letter and or fax dated either May 13, 1998 or
April 20, 1998. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had a tattoo
within 12 months of donation.
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets;
d) Platelets, Pheresis; e) Recovered Plasma.
Recall #B-019/023-9.
CODE
Unit numbers: a) 03V78812, 03G27943, 03M44233, 03FC15556,
03FC20195, 03M61766, 03FT10967, 03FC25483, 03G53472, 03FL37839
b) 03M44233, 03M61766, 03FT10967, 03FC25483
c) 03V78812, 03G27943, 03M44233, 03FC15556, 03FV01385, 03FC20195,
03M61766, 03FT10967, 03FC25483, 03G53472, 03FL37839
d) 03P67256, 03P68999, 03P75118, 03P76163, 03P76967, 03P79776
e) 03V78812, 03G27943, 03FC15556, 03FV01385, 03FC20195, 03G53472,
03FL37839.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter dated April 25, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Georgia and Massachusetts.
QUANTITY
a) 10 units; b) 4 units; c) 11 units; d) 6 units; e) 7 units were
distributed.
REASON
Blood products which tested negative for the antibody to the
human immunodeficiency virus (HIV-1/2), but were collected from a
donor who had previously tested repeatedly reactive for the
antibody, Western Blot indeterminate.
PRODUCT
Red Blood Cells. Recall #B-025-9.
CODE
Unit #18214-4858.
MANUFACTURER
United Blood Services, Cheyenne, Wyoming.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
February 6, 1998. Firm-initiated recall complete.
DISTRIBUTION
Wyoming.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported living in
an area designated as endemic for malaria.
PRODUCT
Red Blood Cells. Recall #B-026-8.
CODE
Unit #12428-9229.
MANUFACTURER
United Blood Services, Albuquerque, New Mexico.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on April
6, 1998. Firm-initiated recall complete.
DISTRIBUTION
New Mexico.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-027/028-9.
CODE
Unit numbers: a) 01KG29821, 01E24426; b) 01KG29821.
MANFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated December 30, 1997. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
a) 2 units; b) 1 unit.
REASON
Blood products were collected from a donor taking the drug
Purinethol.
PRODUCT
Platelets, Pheresis. Recall #B-029-9.
CODE
Unit #4170964B.
MANFACTURER
Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY
Manufacturer, by telephone and fax on June 3, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Alaska.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
PRODUCT
Platelets, Pooled. Recall #B-030-9.
CODE
Unit #P64000.
MANFACTURER
Carter Blood Center, doing business as Carter BloodCare, Bedford,
Texas.
RECALLED BY
Manufacturer, by letter dated August 17, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of clotted red blood
cells.
PRODUCT
Fresh Frozen Plasma. Recall #B-031-9.
CODE
Unit #12412-4424.
MANFACTURER
United Blood Services, Albuquerque, New Mexico.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July
18, 1997, followed by letter on July 31, 1997. Firm-initiated
recall complete.
DISTRIBUTION
New Mexico.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of clotted red blood
cells.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Plasma,
Cryo Poor; e) Recovered Plasma. Recall #B-032/036-9.
CODE
Unit numbers: a) KF24046, KF23109, KQ11430, KQ15925, KQ10330;
b) KF24046, KQ11430; c) KQ15925, KQ10330; d) KQ15925, KQ10330;
e) KF24046, KF23109, KQ11430.
MANFACTURER
Virginia Blood Services, Richmond, Virginia.
RECALLED BY
Manufacturer, by letter dated September 7, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
California, Virginia, Switzerland.
QUANTITY
a) 5 units; b) 2 units; c) 2 units; d) 2 units; e) 3 units were
distributed.
REASON
Blood products were collected from a donor with a history of
jaundice.
PRODUCT
a) Fresh Frozen Plasma; b) Platelets. Recall #B-039/040-9.
CODE
Unit #01LV11764.
MANFACTURER
American Red Cross Blood Services, Buffalo, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by
telephone on January 2 and 15, 1998, and or by letter dated
January 15, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products corresponded to a unit of clotted red blood
cells.
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-042/043-9.
CODE
Unit #KH87772.
MANFACTURER
Virginia Blood Services, Richmond, Virginia.
RECALLED BY
Manufacturer, by letter dated September 15, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Virginia.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
cancer.
PRODUCT
Red Blood Cells. Recall #B-057-9.
CODE
Unit numbers: FF47286, FF44179, and FF41835.
MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame,
California.
RECALLED BY
Manufacturer, by telephone on various dates. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from a donor who traveled to an
area considered endemic for malaria.
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall
#B-058/059-9.
CODE
Unit #FF37263.
MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame,
California.
RECALLED BY
Manufacturer, by telephone on December 27, 1996. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug,
Proscar.
CODE
Unit #FF-48918.
MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame,
California.
RECALLED BY
Manufacturer, by telephone on June 16, 1997. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
PRODUCT
Red Blood Cells. Recall #B-041-9.
CODE
Unit #01LV11764.
MANFACTURER
American Red Cross Blood Services, Buffalo, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by
telephone on January 2 and 15, 1998, and or by letter dated
January 15, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood products corresponded to a unit of clotted red blood
cells.
CODE
Kit Lot 39039M400 EXP 5/7/98.
MANFACTURER
Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY
Manufacturer, by telephone on February 27, 1998 - March 4, 1998,
followed by letter dated February 27, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Arkansas, California, Florida, Georgia, Illinois, Kansas,
Kentucky, Louisiana, Minnesota, New Jersey, New York, North
Carolina, Ohio, Pennsylvania, South Carolina, Texas, Vermont,
Canada.
QUANTITY
119 kits were distributed.
REASON
The two reagent packs that make up AxSYM B12 Dual Pack have the
reagents in the wrong orientation. The reagents that should have
been in Reagent Pack A are in Reagent Pack B and vice versa.
PRODUCT
Abbott Vision Chem Controls Kit, list 1433-02 used for verifying
the performance of specific Chemistry tests on the Abbott Vision
System. Recall #Z-057-9.
CODE
Kit lot 39716M201 EXP 7/19/98.
MANFACTURER
Medical Analysis Systems Inc., Camarillo, California.
RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois,
by "Important Product Information" letters dated 4/13/98.
Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Japan, Brazil, Australia, Germany and Italy.
QUANTITY
779 kits were distributed.
REASON
The Chem Control I failed high for the Amylase, Cholesterol,
Glucose and Triglycerides analytes.
CODE
Lot #142.
MANFACTURER
Cargill, Inc./Nutrena Feeds, Stockton, California.
RECALLED BY
Manufacturer, by visit on June 22, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
California, Arizona, Nevada, Oregon.
QUANTITY
273 bags were distributed.
REASON
Feeds contaminated with salinomycin.
CODE
a) Code dates 225N8 thru 246N8; b) Code dates 225N8 thru
240N8.
MANFACTURER
Blue Seal Feeds, Inc., Bow, New Hampshire.
RECALLED BY
Manufacturer, by telephone on September 10-11, 1998, followed by
visits on September 12, 14, and 15, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
New Hampshire, Massachusetts, Maine, Rhode Island,
Connecticut.
QUANTITY
a) 162.5 tons; b) 41.0 tons were distributed.
REASON
A complaint of lowered egg production due to the protein level of
10.8% instead of the guaranteed 15% on the feed tag.
END OF ENFORCEMENT REPORT FOR OCTOBER 21, 1998. BLANK PAGES MAY FOLLOW.