FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
07/23/1996
ENFORCEMENT REPORT FOR 07/24/96
July 24, 1996 96-30
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Pacific Supreme Sliced Smoked Salmon, 6
ounces. Recall #F-621-6.
CODE Pull Date 27 JUN 96.
MANUFACTURER Three Star Smoked Fish Company, Los Angeles,
California.
RECALLED BY Manufacturer, by telephone on June 13, 1996,
and by press release on June 21, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Arizona, California, Nevada, Oregon,
Washington state.
QUANTITY 3,587 packages were distributed.
REASON Product is contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Mayfair Orange Slices (candy), in 30 ounce
plastic containers. Recall #F-612-6.
CODE All codes.
MANUFACTURER Tzetzo Brothers, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by letter dated May 22, 1996,
followed by telephone and visit. Firm-
initiated recall complete.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY 109 cases were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Magic Farms brand Alfalfa Sprouts.
Recall #F-620-6.
CODE None.
MANUFACTURER Cool Water Farms, also known as Magic Farms,
Salinas, California.
RECALLED BY Manufacturer, by telephone and by letter on
June 30, 1996. Ongoing recall resulted from
sample analysis and follow-up by The State of
California FDA Branch.
DISTRIBUTION Nevada, California.
QUANTITY Approximately 640 pounds are involved in
interstate commerce.
REASON Product is contaminated with Salmonella
montevideo.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III ======
_______________
PRODUCT Shampoo and Baby Bath in 8.1 fluid ounce
bottles. Recall #F-615-6
CODE Catalog #30160, Item Code NA127A, Lot #BL5B1.
MANUFACTURER Bocchi Laboratories, Inc., Walnut, California.
RECALLED BY Shaklee U.S., Inc., San Francisco, California,
by letter on or about July 5, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,635 bottles.
REASON The shampoo and baby bath is labeled as creamy
baby oil.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ==========
_______________
PRODUCT Various liquid oral drug products:
Product Sizes
1. Codal DH Syrup (a) 16 fluid ounces
2. Cyndal HD Syrup (a) 16 fluid ounces
3. Cytra-2 (a) 16 fluid ounces
4. Cytra-3 (a) 16 fluid ounces
5. Cytra-K (a) 16 fluid ounces
6. Cytuss-HC (a) 16 fluid ounces
7. Dinex Grape (a) 16 fluid ounces
8. Dy-G (a) 16 fluid ounces
9. Dyline GG (b) 16 fluid ounces
-2- 10. Dylix Elixir (c) 16 fluid ounces
11. G-Tuss (b) 1 fluid ounce
16 fluid ounces
12. Gani Tuss DM NR (a) 16 fluid ounces
13. Gani-Tuss NR (a) 16 fluid ounces
14. Hist HC (b) 16 fluid ounces
15. Hist Plus (b) 16 fluid ounces
16. Histex (d) 16 fluid ounces
17. Levall (d) 1 fluid ounce
16 fluid ounces
18. PC-Hist (a) 16 fluid ounces
19. Polytussin-XP (e) 16 fluid ounces
20. Tuss-DS (b) 1 fluid ounce
16 fluid ounces
21. Tuss-HC (b) 1 fluid ounce
16 fluid ounces
22. Tuss-PD (b) 1 fluid ounce
23. Vetuss-HC (a) 16 fluid ounces
In addition, the following repacked capsules
and tablets are subject to recall:
24. Ceta-Plus Capsules (b) 25 capsules and
100 capsules
25. Lobac Capsules (b) 25 capsules
100 capsules
26. Meni-D Capsules (b) 25 capsules
100 capsules
27. ND Clear Capsules (b) 25 capsules
28. Tenake Capsules (b) 25 capsules
29. Versacaps Capsules (b) 25 capsules
30. Dyline-GG Tablets (b) 100 tablets
31. Gua-SR Tablets (b) 25 tablets
100 tablets
32. Panlor Tablets (f) 100 tablets
33. Pannaz Tablets (f) 100 tablets
34. V-Dec-M Tablets (b) 25 tablets.
Recall #D-174/207-6.
(a) Labeled as Marketed by: Cypress
Pharmaceutical, Inc., Ridgeland, Mississippi.
(b) Seatrace Pharmaceutical brands.
(c) Labeled as Distributed by: Lunsco, Inc.,
Pulaski, Virginia
(d) Labeled as Marketed by: Salix
Pharmaceuticals, Inc., Ridgeland, Mississippi
(e) Labeled as Distributed by: Poly
Pharmaceuticals, Inc. Mobile, Alabama
(f) Labeled as Manufactured For Pan American
Laboratories, Inc., Covington, Louisiana.
CODE Products 1 thru 7 -- All Lots
8. Lot #95001
9. Lot numbers: 94001, 94002, 94003
Products 10 thru 19 -- All Lots
-3- 20. All Lots (1 fluid ounces),
Lot numbers: 95018TDS, 96049TDS (16 fluid
ounces)
21. All Lots (1 fluid ounces)
Lot numbers: 95012THC, 95020THC (16 fluid
ounces)
Products 22 and 23 -- All Lots
24. All lots (25 capsules)
Lot #940685F (100 capsules)
Products 25 and 26 -- All Lots
26. All Lots (25 capsules)
Lot #95007MD (100 capsules)
Products 27 thru 29 -- All Lots
30. Lot #96033DGT
31. All Lots
32. Lot numbers: 930821J, 95009PL
33. Lot #8362
34. All Lots.
MANUFACTURER Seatrace Pharmaceuticals, Inc., Rainbow City,
Alabama.
RECALLED BY Manufacturer, by letter on July 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Russia.
QUANTITY Undetermined.
REASON Current good manufacturing practice
deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Ecotrin 325 mg Enteric Coated Tablets, in 4
count blister sample packs -- non-
prescription single ingredient, enteric coated
aspirin. Recall #D-208-6.
CODE Product code: 60LAC05 (7 Lot numbers).
Lot# 5C06A, EXP 6/96, Lot# 5D24A, EXP 7/96,
Lot# 5G17A, EXP 9/96, Lot# 5H28A, EXP 1/97,
Lot# 5L04A, EXP 4/97, Lot# 5I04A, EXP 1/97
Lot# 5L11A, EXP 4/97.
MANUFACTURING Smith Kline Beecham/Consumer Healthcare,
Cidra, Puerto Rico.
RECALLED BY Smith Kline Beecham/Consumer Healthcare,
Parsippany, New Jersey, by telephone on
February 27, 1996, followed by letter. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,097 "repack" cases (72 cartons per case)
were distributed.
REASON Product does not meet stability
specifications.
-4- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-512/513-6.
CODE Unit #E07337.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letter on February 21, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who
received a tissue transplant (surgery) within
a year of donation, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Synchron CX7 Delta and Synchron CX 4CE/CX7,
Part #469800, automated and computer
controlled instruments designed for in-vitro
diagnostic quantitation of biological fluid
components and therapeutic drugs as well as
the qualitative determination of drugs of
abuse in urine. Recall #Z-962-6.
CODE All 4.0 Synchron CX Quantum IV version 4.0
Software.
MANUFACTURER Beckman Instruments, Brea, California.
RECALLED BY Manufacturer, by letter on February 12, 1996.
Firm-initiated recall field correction
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 534 units were distributed.
REASON The OFF-Line edit feature of the software is
faulty, causing patient results to be appended
to the record of another patient, which may
result in inappropriate treatment.
_______________
PRODUCT Saturne Linear Accelerators, used for the
treatment of superficial, shallow and deep
seated tumors. Recall #Z-963-6.
CODE All models except Model 800 units.
MANUFACTURER GE Medical Systems, S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Waukesha, Wisconsin,
by issuing field modification instructions on
or about March 15, 1996. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 36 units.
REASON The supplemental add-on beam trimmer locking
mechanisms can break, allowing the beam
trimmers to fall.
-5- _______________
PRODUCT Modified F-10 Culture Medium, Formula
#94-0155PG, 100 mL, for use in sperm
washing/handling. Recall #Z-969-6.
CODE Lot #16P1349 EXP 11/30/95.
MANUFACTURER Life Technologies, Inc., Grand Island, New
York.
RECALLED BY Manufacturer, by letter dated April 11, 1995.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 180 units were distributed.
REASON The device contained bacterial contamination
and was labeled "Sterile."
_______________
PRODUCT Apelio Series Punch/Laser Combination Metal
Working Machines, used for punching and
cutting metal. Recall #Z-970-6.
CODE None.
MANUFACTURER Amada Company, Buena Park, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan July 8, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Some of the laser products failed to comply
with the Federal performance standard for
laser products, 21 CFR 1040.10 in that the
machines lacked the required warning logotype,
aperture label and protective housing labels;
a product report had not been submitted; the
user manual lacked some required information
and quality control procedures were not
adequate to verify compliance with the laser
performance standard.
_______________
PRODUCT DioLase Low Power Biostimulation Laser Model
100, used for biostimulation, pain treatment.
Recall #Z-971-6.
CODE Model 100.
MANUFACTURER DioLase Corporation, Berkeley, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan July 15, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 34 units.
REASON The device failed to comply with the Federal
laser product performance standard, 21 CFR
1040.10 and 1040.11, in that it lacked a
remote interlock connector, emission delay,
calibration procedures and schedule, labels,
and required information.
-6- _______________
UPDATE Allergan AMO Phacoflex II SI 40 NB Intraocular
Lenses, Recall #Z-945-6, which appeared in the
July 10, 1996 Enforcement Report should read
CODE: Serial numbers: 9602010345 through
9603004406, where the fifth digit is a '0'
(zero)".
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT AMO Phacoflex II Intraocular Lens,
Model SI-30NB. Recall #Z-964-6.
CODE Serial numbers: 9507713263 through 9507728420,
9508700001 through 9508744671, 9509700001
through 9509746249, 9510700001 through
9510751212.
MANUFACTURER AMO-Puerto Rico, Anisco, Puerto Rico.
RECALLED BY Allergan, Inc., Irvine, California, by letter
on July 19, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 154,533 units were distributed.
REASON The lenses are becoming discolored and appear
yellow in appearance.
_______________
PRODUCT F-12 (HAM) Nutrient Mixture, Catalog #11765-
047,in 1000 mL bottles, for in-vitro
diagnostic use. Recall #Z-965-6.
CODE Lot #11Q4051 EXP 1/30/96.
MANUFACTURER Life Technologies/GIBCO, Paisley, Scotland.
RECALLED BY Life Technologies, Inc., Grand Island, New
York, by letter dated April 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Michigan, Massachusetts, New Jersey,
Pennsylvania, Alabama, California, North
Carolina, Illinois.
QUANTITY 367 units were distributed.
REASON Bacterial contamination.
_______________
PRODUCT McCoy's 5A Medium Cell Culture Media, Catalog
#16600-082, for in-vitro diagnostic use.
Recall #Z-966-6.
CODE Lot #15F3844 EXP 11/30/95.
MANUFACTURER Life Technologies/GIBCO, Paisley, Scotland.
RECALLED BY Life Technologies, Inc., Grand Island, New
York, by letter May 2, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Hong Kong, Japan.
QUANTITY 443 units were distributed.
-7- REASON Bacterial contamination.
_______________
PRODUCT RPMI-1640 Medium, 1000 mL, Catalog #21870-027,
an in-vitro diagnostic for cell culture or
further manufacturing uses. Recall #Z-967-6.
CODE 14Q3744 EXP 11/30/96.
MANUFACTURER Life Technologies/GIBCO, Paisley, Scotland.
RECALLED BY Life Technologies, Inc., Grand Island, New
York, by letter dated May 12, 1995. Firm-
initiated recall complete.
DISTRIBUTION Florida, Michigan, Pennsylvania, California,
Ohio, Connecticut.
QUANTITY 362 units were distributed.
REASON Bacterial contamination.
_______________
PRODUCT Dulbecco's Modified Eagle Medium (D-MEM),
Catalog #11885-050, in 500 mL bottles, an in-
vitro for cell culture or further
manufacturing uses. Recall #Z-968-6.
CODE Lot #22N1051 EXP 12/30/95.
MANUFACTURER Life Technologies, Inc., Grand Island, New
York.
RECALLED BY Manufacturer, by letter dated April 28, 1995.
Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Colorado, North Carolina.
QUANTITY 1,222 units were distributed.
REASON Yeast contamination.
_______________
PRODUCT Patient Guide Companionr 318 Nasal CPAP
System, used for the treatment of obstructive
sleep apnea:
(a) Companionr 318 Nasal CPAP Home Care
Assembly, Catalog No. 126800-00
(b) Companionr 318 Nasal CPAP Home Care
Assembly without the Hourmeter, Catalog No.
126804-00. Recall #Z-972/973-6.
CODE Lot numbers: (a) 512141D, 512142D, 512191B,
601021D, 601111D, 601291D, 602121D,602271D,
603041D, and 603131D;
(b) 512111B, 512181B, 512271B, 602051B,
601081B, and 601231B.
MANUFACTURER Lithographics, Overland Park, Kansas (patient
guide).
RECALLED BY Nellcor Puritan Bennett Corporation, Lenexa,
Kansas, by letters dated May 23 or 24, 1996.
Firm-initiated field correction ongoing
DISTRIBUTION Nationwide, Canada.
QUANTITY 2,247 manuals were distributed.
REASON Some of the patient guides had sections
omitted.
-8- ________________
PRODUCT Kodak T-Mat Diagnostic X-Ray films:
(a) T-MAT G/RA, Exp. dates: 5/98 and 6/98
Catalog No. 1295302, 35 x 43 cm
Catalog No. 1928605, 35 x 43 cm
Catalog No. 1373125, 35 x 43 cm
Catalog No. 8218752, 35 x 43 cm
Catalog No. 8301905, 35 x 35 cm
Catalog No. 1517887, 30 x 35 cm
Catalog No. 1510023, 24 x 30 cm
Catalog No. 1517473, 24 x 24 cm
Catalog No. 8378101, 14 x 51 in.
Catalog No. 1746049, 14 x 36 in.
Catalog No. 8261836, 10 x 12 in.
Catalog No. 8404709, 10 x 12 in.
Catalog No. 1756196, 8 x 10 in.
Catalog No. 1464957, 5 x 7 in. (dental only)
Catalog No. 1869080, 15 x 30 cm (dental only)
(b) T-MAT L/RA, Exp. dates: 5/98 and 6/98
Catalog No. 1744788, 35 x 43 cm
Catalog No. 1814631, 35 x 43 cm
Catalog No. 8416133, 35 x 43 cm
Catalog No. 1799980, 30 x 35 cm
Catalog No. 1709039, 24 x 30 cm
Catalog No. 8364911, 24 x 30 cm
Catalog No. 8408858, 24 x 24 cm
Catalog No. 8172413, 24 x 24 cm
Catalog No. 8410789, 18 x 24 cm
Catalog No. 8310286, 13 x 43 cm
Catalog No. 8447054, 11 x 14 in
Catalog No. 8480410, 11 x 14 in
Catalog No. 8407710, 8 x 10 in
Catalog No. 1163948, 8 x 10 in
Catalog No. 1589852, 8 x 10 in (dental only)
(c) T-MAT S/RA, Exp. date: 5/98
Catalog No. 1247063, 35 x 43 cm
Catalog No. 8341422, 24 x 30 cm
Catalog No. 8051419, 8 x 10 in
Catalog No. 8999245 (Kodak ClinicSelect -
CSG/1)
(d) T-MAT H/RA, Exp. date: 5/98
Catalog No. 1827286, 35 x 43 cm
Catalog No. 1085521, 35 x 35 cm
Catalog No. 8456253, 18 x 43 cm
Catalog No. 8210957, 14 x 51 in
Catalog No. 8200826, 14 x 36 in
Catalog No. 1525963, 10 x 12 in
Catalog No. 1449206, 8 x 10 in
Catalog No. 1067529, 15 x 30 cm (dental only)
Catalog No. 1091057, 5 x 10 7/8 in (dental
only)
Catalog No. 1763044, 5 x 12 in (dental only)
-9- Catalog No. 1975747 (Kodak ClinicSelect -
CSG/2)
Catalog No. 8202988 (Kodak ClinicSelect -
CSG/2)
Catalog No. 8793846 (Kodak ClinicSelect -
CSG/2). Recall #Z-974/977-6.
CODE Approximately 600 emulsion ID numbers are
involved.
MANUFACTURER Eastman Kodak Company, Windsor, Colorado.
RECALLED BY Eastman Kodak Company, Rochester, New York, by
E-mail dated June 7 and 20, 1996, by letters
of June 11 and 14, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 55,729 boxes were distributed.
REASON The firm's internal product testing revealed a
small quantity of the subject products could
exhibit a series of plus density artifacts in
the form of round spots and straight lines due
to static discharge in the manufacturing
process. There is a possibility that these
artifacts could necessitate a repeat of a
patient exposure.
-10-
END OF ENFORCEMENT REPORT FOR JULY 24, 1996. BLANK PAGES MAY FOLLOW.
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