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 contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
12/09/1992
RECALLS AND FIELD CORRECTIONS: December 9, 1992
FOODS -- CLASS I
92-50
PRODUCT Osmolite Isotonic Liquid Nutritional Supplement, in 8 ounce cans.
Recall #F-091-3.
CODE Lot #L5 EO 67799 EXP 8/93 (cans), Aug 93 67799 L5 (cases).
MANUFACTURER Ross Laboratories, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter September 23, 1992, and by telephone
between September 23 and 25, 1992. Firm-initiated recall
complete.
DISTRIBUTION New York, New Jersey, Ohio, Arkansas, Pennsylvania, West
Virginia, Louisiana, Israel.
QUANTITY 81,456 cans are subject to recall.
REASON Potential for Clostridium botulinum toxin outgrowth.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT DecoPac brand Candy Pebbles, jelly beans, 5 pounds, packaged in
clear plastic bag contained in a cardboard box. Recall #F-117-3.
CODE None.
MANUFACTURER Sweet Candy Company, Salt Lake City, Utah.
RECALLED BY DecoPac, division of McGlynns Bakeries, Inc., Eden Prairie,
Minnesota, by letter November 4, 1992. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 744 boxes were distributed; firm estimates 200 boxes remain on
the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT McCain Eeny Meeny Miney Moo Chocolate Flavored Drink, 50% whole
milk, in 4.2 fluid ounce aseptic fill boxes. Recall #F-120-3.
CODE All lots.
MANUFACTURER White Knight Packaging, Wyoming, Michigan.
RECALLED BY McCain Citrus, Inc., Chicago, Illinois, by telephone and by
letter October 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Illinois, New Jersey, New York, Massachusetts, Vermont, Maine,
Connecticut, Pennsylvania, Maryland, North Carolina, South
Carolina, Virginia, Florida, Tennessee, Georgia, Washington, D.C.
QUANTITY 11,500 cases (44 boxes per case) were distributed; firm
estimates none remains on the market.
REASON Product was contained in leaking containers.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Pseudo-gest Plus Decongestant Plus Antihistamine, in bottles of
100. Recall #D-073-3.
CODE Lot #P8126.
MANUFACTURER LNK International, Hauppague, New York.
RECALLED BY Manufacturer, by letter October 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,876 bottles were distributed.
REASON A bottle labeled Pseudo-gest Plus was found to contain
children's chewable aspirin.
PRODUCT Selenium Sulfide Lotion, USP, 2.5%, in 4 fluid ounce bottles, a
Rx liquid antiseborrheic, antifungal preparation for topical
application for the treatment of dandruff and seborrheic
dermatitis, under the following labels: PBI, Bioline, GG,
Goldline, Major, H.L. Moore, Qualitest, Rugby, URL.
Recall #D-075-3.
CODE All unexpired lots.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter November 20, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, West Indies, Barbados.
QUANTITY 633,150 bottles were distributed; firm estimates 40 percent of
the product remains on the market.
REASON Preservative system not effective through expiration date.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Procainamide hydrochloride Extended-Release Tablets, USP, 500
mg, hospital unit dose, packaged in carton boxes containing 10
blister packs (100 tablets), a Rx cardiac drug. Recall #D-074-3.
CODE Lot #40861D EXP 3/93.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Schein Pharmaceutical, Inc., Port Washington, New York, by
letter October 15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates that less than 100 units, if any at all, remain
on the market.
REASON Repackaged product contained package inserts for Procainamide
Capsules instead of the insert for Procainamide HCl ER Tablets.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Array 360 Protein/Drug System, Software Version, 3.5, Part
#448149, and consists of two diskettes, identified as Part
448151 and Part 448152. Recall #Z-006-3.
CODE All version 3.5 software.
MANUFACTURER Beckman Instruments, Inc., Brea, California.
RECALLED BY Manufacturer, by letters of March 11 and 12, 1992.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 390 software packages were distributed.
REASON Two panel definition requirements were not included in the
software installation instructions. This may cause a failure to
detect antigen excess conditions, resulting in falsely decreased
results.
PRODUCT Hewlett Packard HP 78560A Central Station Monitor, displays data
from six bedside monitors. Recall #Z-007-3.
CODE Serial prefix date codes 3002A or greater.
MANUFACTURER Hewlett Packard Company, Waltham, Massachusetts.
RECALLED BY Manufacturer, by letter May 8, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,165 monitors were distributed.
REASON An audible alarm signaling an INOP condition may not resound a
second time after an unvalidated/reset short yellow alarm from
any other patient or a nurse call alarm from any patient is
triggered.
PRODUCT Cartridge Oxygenation Kit for Fluosol 20% Intravascular
Perflourochemical Emulsion. Recall #Z-009-3.
CODE Component lot #C06-92-037, kits lot numbers: KF2006A, KF2007A,
KF2008A.
MANUFACTURER Craft Tech, Anaheim, California.
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RECALLED BY Alpha Therapeutics, Los Angeles, California, by telephone, July
21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Colorado, Connecticut, Georgia, Illinois,
Massachusetts, Minnesota, Missouri, Ohio, Texas, Utah, Virginia,
West Virginia.
QUANTITY 17 units were distributed.
REASON The filter may be defective and the device may not achieve a p02
of greater than 450 mm Hg whereas labeling indicates it should
reach 600 mm Hg.
PRODUCT Synchron Positive Sample Identification Systems:
(a) Model CX4CE; (b) Model CX5CE; (c) Model CX7.
Recall #Z-010/012-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Beckman Instruments, Inc., Diagnostic Systems Group, Brea,
California.
RECALLED BY FDA approved the firm's corrective action plan September 23,
1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 762 units were distributed.
REASON Noncompliance with the Federal Performance Standard for Laser
products in that they lacked adequate warning logotype label and
aperture label as required.
PRODUCT Insulin Syringe Micro-Fine IV Needle, 3/10 cc for 30 units or
less u-100 Insulin. Recall #Z-040-3.
CODE Lot #1A204, catalog #8430.
MANUFACTURER Becton-Dickinson & Company, Consumer Products Division,
Holdrege, Nebraska.
RECALLED BY Becton-Dickinson & Company, Consumer Products Division,
Franklin, New Jersey, by letter September 6, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,175,500 units were distributed; firm estimates 748,593 units
remain on the market.
REASON The syringes have a misalignment in the scale.
PRODUCT Merit Custom Kit (convenience kit):
(a) Catalog #K05-00160 (contains BX3000 BASIX Syringe with
M.A.P.;
(b) Catalog #K05-00070 (contains BX3001 BASIX Syringe with
Primelok);
(c) Catalog #K05-00121 (contains IN2001 Monarch Syringe with
Primelok).
(d) Catalog #K05-60220 (contains IN2001 Monarch Syringe with
Primelok). Recall #Z-042/045-3.
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CODE Lot numbers: 082004-20; (b) 080331-2, 081898-2;
(c) 082002-50; (d) 081793-8.
MANUFACTURER Merit Medical Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone or by visit on July 28, 1992.
Firm-initiated recall complete.
DISTRIBUTION Texas, Missouri, Pennsylvania, Florida.
QUANTITY Firm estimates none remains on the market.
REASON The product's sterility cannot be certified.
PRODUCT Argyle 2.5 mm pediatric tracheal tubes, oral/nasal, single-use.
Recall #Z-063-3.
CODE Catalog #1180-239616 (Magill Tip), lot numbers: 89H284B,
90K051B, 90E077B, 91D045B;
Catalog #1180-239418 (Murphy Tip), lot numbers: 89G041B,
89G201B, 89H147B, 90F158B, 90K052B, 91A166B.
MANUFACTURER Sherwood Medical Industries of Ireland, Ltd., Tullamore, County
Offaly, Republic of Ireland.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letter August
18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24,100 tubes of catalog #1180-239616 and 60,160 tubes under
catalog #1180-239418.
REASON Some of the tubes may contain a constriction of the internal
diameter at the distal tip.
PRODUCT Disposable Condensate Bottles, used as attachments to
ventilators to collect moisture. Recall #Z-064-3.
CODE Lot numbers: 91644, 97921, 101941. The identification number
is DHD55-5800.
MANUFACTURER DHD Diemolding Healthcare Division, Wampsville, New York.
RECALLED BY DHD Diemolding Healthcare Division, Canastota, New York, by
letter August 10, 1992, followed by telephone August 11, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,180 units were distributed; firm estimates 60 percent of the
product remains on the market.
REASON Two units were occluded.
PRODUCT Mammary Prostheses, gel-filled:
(a) Style 40: Round, Intrashiel (low bleed), 80 cc to 800 cc
sizes, ordered under Catalog Nos. 25-40081 through 25-40801;
(b) Style 45: Round, High Profile, Intrashiel, 120 cc to 800 cc
sizes, ordered under Catalog Nos. 25-45121 through 25-45801;
(c) Style 46: Round, Double-lumen, Intrashiel, 100/120 cc to
700/800 cc sizes, ordered under Catalog Nos. 25-46101 through
25-46701;
(d) Style 110: Round, Moderate Profile, Intrashiel, Biocell
Textured, 90 cc to 800 cc sizes, ordered under Catalog Nos.
27-110091 through 27-110801;
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(e) Style 120: Round, High Profile, Intrashiel, Biocell
Textured, 180 cc to 800 cc sizes, ordered under Catalog Nos.
27-120181 through 27-120801;
(f) Style 148: Round, Moderate Profile, UHP (Ultra-High
Performance) Biocell Textured, 120 cc to 510 cc sizes, ordered
under Catalog Nos. 27-148121 through 27-148511;
(g) Style 153: Anatomical, Intrashiel, Biocell Textured
Gel-Filled, 360 cc to 720 cc sizes, ordered under Catalog Nos.
27-153361 through 27-153721;
(h) Style 156: Round, High Profile, Tri-Lumen, UHP Biocell
Textured, Gel-Filled, 200/220 cc to 700/800 cc sizes ordered
under Catalog Nos. 27-156201 through 27-156701;
(i) Style 178: Round, Double-Lumen, UHP Biocell Textured,
Gel-Filled, 140/160 cc to 400/440 cc sizes, ordered under
Catalog Nos. 27-178141 through 27-178401;
(j) Style 246: Round, Standard Profile, UHP, Gel-Filled, 180 cc
to 560 cc sizes, ordered under Catalog Nos. 25-146181 through
25-146561;
(k) Style 256: Round, High Profile, Tri-Lumen, UHP, Gel-Filled,
200/220 cc to 700/800 cc sizes, ordered under Catalog Nos.
25-2562201 through 25-256701;
(l) Style 278: Round, Moderate Profile, Souble-Lumen, UHP
Textured, Gel-Filled, 200/220 cc to 320/360 cc sizes, ordered
under catalog Nos. 25-278201 through 25-278321.
Recall #Z-065/076-3.
CODE All lot numbers.
MANUFACTURER McGhan Medical Corporation, Santa Barbara, California.
RECALLED BY Manufacturer, by letters dated July 29 and 31, 1992, September
3, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates 5,945 units remain on the market.
REASON The devices must be reprocessed in order to make modifications
in such areas as packaging, labeling, and other manufacturing
procedures.
PRODUCT Custom Body Prostheses, used for contour augmentation and
correction of cosmetic anomalies:
(a) Pectus Muscle; (b) Pectus Excavatum; (c) Mammary Prosthesis
with Pectus Muscle Attached; (d) Calf Implants; (e) Buttock
Implants. Recall #Z-077/081-3.
CODE All serial numbers.
MANUFACTURER CUI Corporation, Carpinteria, California.
RECALLED BY Manufacturer, by letter dated May 14, 1992, and by telephone
beginning May 22, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Illinois, New York, Ohio, South Carolina,
Texas, Utah, Washington state, Wisconsin.
QUANTITY (a) 25 units; (b) 24 units; (c) 5 units were distributed.
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REASON The devices were labeled with inserts entitled "Custom
Prosthetic Implants," but the devices are not custom devices as
defined in the Code of Federal Regulations. In addition, no
premarket notification (510(k)) or premarket approval (PMA) was
submitted and approved.
PRODUCT Software Programs for the Electro-Physio-Biofeedback-Xrroid
System, a biofeedback system used primarily by chiropractors,
dentists, and physicians interested in homepathic diagnosis and
treatments. Recall #Z-084-3.
CODE Serial numbers1010100 through 1010246.
MANUFACTURER Eclosion, Inc., Commerce City, Colorado.
RECALLED BY Manufacturer, by letter July 3, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, England, Canada, Italy, Australia, British Colombia,
Ireland.
QUANTITY 139 units were distributed.
REASON The firm had made unapproved changes and revisions to the
software program. These claims were found to deviate
significantly from the 510(k) submitted.
PRODUCT Mercury Medical Child or Infant CPR Bags:
(a) Catalog # 10-55104 Child Bag with cushion mask accumulator
and oxygen tubing;
(b) Catalog #10-55103 Child Bag less mask, with accumulator and
oygen tubing;
(c) Catalog #10-55102 Child Bag only;
(d) Catalog #10-55204 Infant Bag with cushion mask accumulator
and oxygen tubing;
(e) Catalog #10-55203 Infant Bag less mask, with accumulator and
oxygen tubing;
(f) Catalog #10-55202 Infant Bag only. Recall #Z-095/100-3.
CODE Lot numbers: (a-c) 911212 through 920327; (d-f) 911210 through
920331.
MANUFACTURER Mercury Medical Clearwater, Florida.
RECALLED BY Manufacturer, by letter April 16, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Venezuela.
QUANTITY 4,795 cases (6 units per case) were distributed.
REASON The neck bushing on the bag may be cracked which could
compromise the ability of the device to ventilate.
PRODUCT Jelco I.V. Stylets, sterile obturators intended for use with IV
catheters as a means to maintain a patient's IV line when
administering intermittent IV therapy. Recall #Z-102-3.
CODE Product/catalog numbers: 4102, 4104, 4105, 4106, 4107, 4108,
4109, 4111. All model numbers and all lot numbers.
MANUFACTURER Jelco Labs, Raritan, New Jersey, Critikon, Inc., Sathington,
Connecticut; Johnson and Johnson, Sezanne, France, and Adams
Spence Corporation, Wall Township, New Jersey.
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RECALLED BY Critikon, Inc., Tampa, Florida by, letter July 2, 1992, to
domestic accounts, and July 17, 1992, to foreign accounts.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,752,000 units were distributed; firm estimates less than 5,000
units remain on the market.
REASON A piece of the device may break off during use and be retained
in the patient.
PRODUCT NewVues disposable Soft Contact Lenses. Recall #Z-103-3.
CODE Lot numbers: 752190, 762470, 762940, 758430, 751890, 762370.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter June 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 46,350 lenses of 7725 multipacks were distributed.
REASON The contact lens multipacks may have been filled with a mixture
of glycerin and water/saline instead of the standard saline
solution.
PRODUCT Arterial Blood Gas Kit containing Micro A.B.G. Syringes, used
for adult, pediatric, and neonatal blood gas collection.
Recall #Z-104-3.
CODE Product code P-9525, lot 64726 (containing Micro syringe lot
#64586).
MANUFACTURER Marquest Medical Products, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by letter October 8, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 15,000 kits were distributed.
REASON The kit may contain QUIK syringes instead of MICRO syringes.
QUIK syringes have a 3 cc barrel and are fitted with a 23 g x 1"
needle instead of having a 1 cc barrel with a 25 g x 5/8" needle.
PRODUCT Nanticoke laparoscopic hand instruments:
(a) Nanticoke 2 Finger Retractor, Catalog #005178-904;
(b) Nanticoke 3 Finger Retractor, Catalog #005178-901;
(c) Nanticoke Patch Spreader, Catalog #005178-903.
Recall #Z-105/107-3.
CODE Lot numbers: (a & b) C2021-A2; (c) 2G1157 through 2G1222.
MANUFACTURER Cabot Medical Corporation, Langhorne, Pennsylvania.
RECALLED BY Manufacturer, by letter September 3, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 11 units; (b) 3 units; (c) 51 units were distributed.
REASON The nickel plating/coating on the inside surface of the shaft of
the instruments may flake off when passing the Patch Spreader or
Retractor insert through the shaft.
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PRODUCT Patient Walker Seat Accessory, Model 7870. Recall #Z-121-3.
CODE All units.
MANUFACTURER Guardian Product, Inc., North Hollywood, California.
RECALLED BY Guardian Product, Inc., Arleta, California, by letter September
8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan, Italy.
QUANTITY 1,167 units were distributed.
REASON The small threaded bushings (plastic nuts) used to secure the
seat hooks to the walker legs fail to function as intended, and
could allow the seat to slip while in use.
PRODUCT Ultratherm Disposable Fluid Warmer, Model 3703-1, indicated for
use as a warmer for fluids such as blood plasma, saline solution
and nutritional fluids which are about to be infused into a
patient. Recall #Z-123-3.
CODE All codes.
MANUFACTURER PMT Corporation, Chanhassen, Minnesota.
RECALLED BY Manufacturer, by letter dated October 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 15,000 units were distributed.
REASON The device lacked adequate warning and directions for use.
There are no instructions for use on the device itself. There is
no 510(k) submission for the Model 3703-1.
PRODUCT Contra Angle Head Reduction 1:1, for Low Speed Contra Angle
Drill, Part #296-18-200. Recall #Z-124-3.
CODE All lot numbers.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter April 22-23, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 51 units were distributed.
REASON The device lacked the appropriate caution labeling against using
with a High Speed Contra Angle Drill (296-18). Use with the
high speed drill could cause overheating, resulting in possible
burn hazard to the patient.
PRODUCT Excel Femoral Canal Irrigation Tips, used to irrigate the
femoral canal during a hip replacement or revision surgery:
(a) Part No. 207-130, Lot Nos. 92010082, 91121962, 91122022,
91061042, 91071222, 91081322, 91101582, 91111922;
(b) Part No. 280-14-650, Lot No.92010082;
(c) Part No. 200-113, Lot Nos. 91121962, 92010082.
Recall #Z-125/127-3.
CODE Lot numbers: (a) 92010082, 91121962, 91122022, 91061042,
91071222, 91081322, 91101582, 91111922;
(b) 92010082; (c) 91121962, 92010082;
MANUFACTURER Stryker Corporation, Arroyo, Puerto Rico.
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RECALLED BY Stryker Corporation, Kalamazoo, Michigan, by letters of
February 20, 1992, March 27, 1992, and June 9, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 172 units were distributed.
REASON The clear plastic distal tip can come off the shaft either in
the package or during use, because of insufficient bonding.
PRODUCT Contra Angle Head Reduction 1:1 Part #296-18-40.
Recall #Z-129-3.
CODE All lots.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 23, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, The Netherlands.
QUANTITY 26 units were distributed.
REASON The device labeled as 296-18-40 1:1 Head may contain a 296-17-40
10:1 Reduction Contra Angle Head. Use with the incorrect speed
drill could cause overheating, resulting in possible burn hazard
to the patient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Electromedics 21 and 43u Air Star Arterial Filters, a disposable
device intended for blood filtering applications during
cardiopulmonary bypass procedures. Recall #Z-017-3.
CODE Lot numbers: M513700, M524860, M535760.
MANUFACTURER Electromedics, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by letter dated July 23, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Wisconsin, Pennsylvania, California.
QUANTITY 405 finished filter products were distributed.
REASON Products may lead to leaking at the arterial filter housing weld
joint.
PRODUCT Spinal Needle 18G/3.5, Quincke Type Point Reorder #5184,
sterile, single use. Recall #Z-039-3.
CODE Lot #1F908.
MANUFACTURER Becton-Dickinson Division, Micropette, Inc., Juncos, Puerto Rico.
RECALLED BY Becton Dickinson and Company, Rutherford, New Jersey, by letter
January 17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 21,300 units were distributed; firm estimates 19,475 units
remain on the market.
REASON Labeling error. The product shelf carton and case carton are
properly labeled as catalog #5174, 18 x 3" Spinal Needle. The
unit product label is incorrectly labeled catalog #5184, 18 x
3.5" Spinal Needle.
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PRODUCT Medical Calibration Gas mixture of 10% Carbon dioxide, 5% Oxygen
and 85% Nitrogen. Recall #Z-101-3.
CODE Catalog #4020-1000, lot #0L18L96.
MANUFACTURER Puritan Bennett Corporation, Marlborough, Massachusetts.
RECALLED BY Manufacturer, by visit on or about January 8, 1992.
Firm-initiated recall complete.
DISTRIBUITON Rhode Island.
QUANTITY 18 cylinders were distributed.
REASON The boxes containing the cylinders had an incorrect or missing
lot code sticker.
INFORMATIONS:
DEFENDANT John S. Sadlon, former Vice President of Operations, Par
Pharmaceutical, Inc., Spring Valley, New York.
NATURE OF Mr. Sadlon pled guilty to a charge of adulterating a batch
CHARGE of the generic drug product Methyldopa 500 mg. tablets, a
blood pressure medication, by adding the unapproved
ingredient magnesium stearate. Sadlon admitted that in 1987
he was instructed by Par's senior management to falsify
batch records to conceal the addition of the unapproved
ingredient.
FILED October 2, 1992 - U.S. District Court for the District of
Maryland; CR #HAH-92-0336, FDC #66560.
DEFENDANT Dr. Atul Shah, former Director of the Analytical Research
and Development Laboratory, Par Pharmaceutical, Inc., Spring
Valley, New York.
NATURE OF Dr. Shah pled guilty to a one-count Information charging him
CHARGE with making a false declaration to a grand jury during the
government's investigation of Par and its former management.
Dr. Shah admitted that he knowingly lied to the grand jury
in February 1990 about his memory concerning Par's pilot
batch of Triamterene/Hydrochlorothiazide, a generic version
of the blood pressure medication Maxide.
FILED September 30, 1992 - U.S. District Court for the District of
Maryland; CR #HAH-92-0337, FDC #66561.
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END OF ENFORCEMENT REPORT FOR DECEMBER 9, 1992. BLANK PAGES MAY
FOLLOW.
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