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
09/04/1990
FDA Enforcement for the week of September 5, 1990.
FDA ENFORCEMENT REPORT
FOR SEPT. 5, 1990
September 5, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
Product: Opticrom 4 percent Ophthalmic Solution (cromolyn sodium
solution, USP), 10 ml an Rx sterile, topical eye
solution used in the treatment of certain allergic ocular
disorders, Recall #D-338-0.
Code: Lot #KF35V, Exp. 12/91; KF7A, Exp. 1/93.
Manufacturer: Fisons PLC, Pharmaceutical Division, Crewe, Cheshire,
England.
Recalled by: Fisons Pharmaceuticals, Rochester, New York by letters
beginning July 2, 1990. (See FDA Press Release
P90-38 - July 13, 1990.). Firm initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 45,337 units were distributed.
Reason: Bacterial contamination.
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Class II -
Product: Source Plasma, Recall B-177-0.
Code: Unit #65985236.
Manufacturer: Plasma Products, Inc., (doing business as Monroe Plasma
Lab.) Monroe, Louisiana.
Recalled by: Manufacturer, by letter and telephone June 12, 1989.
Firm initiated recall complete.
Distribution: California.
Quantity: 1 unit was distributed.
Reason: A unit of Source Plasma, which tested repeatably reactive
for the antibody to the human immunodeficiency virus,
type 1 (anti-HIV-1) was distributed.
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Product: Red Blood Cells, Recall #B-182-0.
Code: Unit #41KQ13394.
Manufacturer: American Red Cross, Alabama Region-Madison County,
Huntsville, Alabama.
Recalled by: Manufacturer by telephone January 27, 1989. Firm
initiated recall complete.
Distribution: Alabama.
Quantity: 1 unit was disributed.
Reason: Unit drawn from a donor who had a hepatitis exposure
prior to donation, was distributed.
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-2-
Product: Opticrom 4 percent Ophthalmic Solution (cromolyn sodium
solution, USP) in 5 ml plastic bottles (professional
sample), 10 ml (trade) an Rx sterile, topical eye
solution used in the treatment of certain allergic ocular
disorders, Recall #D-338-0.
Code: All lots.
Manufacturer: Fisons PLC, Pharmaceutical Division, Crewe, Cheshire,
England.
Recalled by: Fisons Pharmaceuticals, Rochester, New York by letters
beginning July 26-27, 1990. Firm initiated recall
ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 2,480,944 units were distributed.
Reason: Lack of assurance of sterility.
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Product: Needle Adapter Assembly an Rx product for use with
Minitec (Technetium Tc 99m Generator), Recall #D-341-0.
Code: All lots.
Manufacturer: Bristol Myers Squibb Company, New Brunswick, New Jersey.
Recalled by: Manufacturer, by telephone June 27, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 5,577 adapters distributed from January 1989 to
June 27, 1990.
Reason: Sterilizing filter (.22 micron) in Needle Adapter Assembly
cannot assure the solution passing through will be
sterilized.
----
Product: Proventil brand of Albuteral Sulfate Repetabs Brand of
Extended Release Tablets, 4 mg. in 100 tablet bottles,
an Rx used for the relief of bronchospasm in patients
with reversible obstructive airway disease, Recall
#D-343-0.
Code: Lot #8RDR101, Exp. date 4/91.
Manufacturer: Schering Laboratories, Division of Schering-Plough Corp.
Kenilworth, New Jersey.
Recalled by: Manufacturer, by letter July 12, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 41,049 bottles were distributed.
Reason: Product does not meet dissolution test specifications.
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Product: Brethine brand (terbutaline sulfate USP) 5 mg. tablets, an
Rx bronchodilator used for bronchial asthma in 12/100
tablet bottles, Recall #D-348-0.
Code: Lot #1B113541, Exp. date 2/94.
Manufacturer: Ciba-Geigy Pharmaceuticals Division, Summit, New Jersey.
Recalled by: Manufacturer, by letter July 17, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 39,660/100 tablet bottles were shipped, firm estimates
7,000/100 tablet bottles remain on market.
Reason: A bottle was found to contain an Esimil tablet
(guanethidine monosulfate 10 mg., hydrochlorothiazide
25 mg.).
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Class III -
Product: (a) 2% Xylocaine Injection 20 mg/ml with
Epinephrine; (b) 4% Citainest Forte (Prilocane HCL)
Injection 40 mg/ml with Epinephrine, used for local
anesthesia in dentistry, Recall #D-339/340.
Code: (a) 906067, exp. date 12/90; 906068, exp. date 12/90;
906126, exp. date 12/90; 908079, exp. date 2/91; (b)
903110, exp. date 9/90.
Manufacturer: Astra Pharmaceutical Products, Inc., Westborough,
Massachusetts.
Recalled by: Manufacturer, by letter August 3, 1990. Firm initiated
recall ongoing.
Distribution: Arkansas, South Dakota, Alabama, Kansas, Florida,
South Carolina.
Quantity: 2,000,000 cartridges were distributed.
Reason: Product is subpotent for epinephrine.
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Product: Tindal brand Acetophenazine Maleate Tablets, 20 mg.
tablets in 100 tablet bottles, an Rx orally used for
the management of manifestations of psychotic disorders,
Recall #D-342-0.
Code: Lot #'s 7BBA-1, exp. date 3/92; 8BBA-1, exp. date 3/92;
9BBA-1, exp. date 2/94; 9BBA-2, exp. date 3/93.
Manufacturer: Schering Laboratories (division of Schering-Plough Corp.)
Kenilworth, New Jersey.
Recalled by: Manufacturer, by letter July 3, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 15,000/100 tablet bottles were distributed.
Reason: Product may not meet dissolution requirements through
expiration date.
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Product: Imferon (iron dextran injection, USP) in 10 ml. multidose
vial, an Rx for intramuscular use in patients with
documented iron deficiency in whom oral administration is
unsatifactory or impossible, Recall #D-344-0.
Code: Lot #EC305W, Exp. date 10/92.
Manufacturer: Fisons PLC, Pharmaceutical Division, Crewe, Cheshire,
England.
Recalled by: Fisons Pharmaceuticals, Rochester, New York by letter
July 24, 1990. Firm initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Honduras.
Quantity: 12,402 units were distributed.
Reason: Product does not meet USP requirements for particulate
matter.
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Product: PanOxyl AQ Acne Gel in 2 1/2%, 5% and 10% strength
packaged in 2 oz. and 4 oz. tubes, a topical Rx
medication used in the treatment of acne vulgaris,
Recall #D-345/347-0
Code: All products ending in the letter "P".
Manufacturer: Stiefel Laboratories, Inc., Mayaguez, Puerto Rico.
Recalled by: Stiefel Laboratories, Inc., Oak Hill, New York by
letters July 9, and July 13, 1990. Firm initiated recall
ongoing.
Distribution: New York, Puerto Rico.
Quantity: Approximately 350,000 units were distributed. Firm
estimates less than 10,000 units remain on market.
Reason: Some lots have exhibited a loss of viscosity.
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Product: Chlorpromazine HCl Oral Solution, 100 mg per 3.4 ml
an Rx oral liquid psychotropic used for the management
of manisfestations of psychotic disorders, Recall #D-349-0
Code: Lot #003605, exp. date 9/91.
Manufacturer: Roxane Laboratories, Columbus, Ohio.
Recalled by: Xactdose, Inc., South Beloit, Illinois by letter July 13,
1990. Firm initiated recall ongoing.
Distribution: New York, Ohio, Indiana Wisconsin, California.
Quantity: 113 cases were distributed.
Reason: The solution reacted to the aluminum foil cup, causing
leaking containers.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
-5-
Product: Liberator 20 Oxygen System, an Rx liquid oxygen device
used for providing a controlled rate of oxygen flow to
a patient, Recall #Z-797-0
Code: Serial #'s 119019001 thru 119019010; 119022015 thru
119022030.
Manufacturer: Cryogenic Associates (Medical Division of Minnesota
Valley Engineering, Inc.) New Prague, Minnesota.
Recalled by: Manufacturer by telephone on or about June 13, 1990.
Firm initiated recall ongoing.
Distribution: Connecticut, Massachusetts, Canada.
Quantity: 21 units were distributed.
Reason: The device did not meet specifications for oxygen pressure
affecting oxygen flow rate, during extended use because
of an incomplete weld on a liquid oxygen line.
----
Product: MTP Transport Infusion Pump, Model 1001A used for
infusion of I.V. solutions and blood at desired flow
rate and volume which can be preprogrammed by user or
operator, Recall #Z-798-0
Code: Serial #'s 1291 thru 1305; 1644 thru 1717; 2230,
2231; 1979, 1989, 1997, 1998, 2123, 2228, 2229, 2234,
2246 thru 2248, 2416; 2235; 1571, 1578, 1730, 1736,
1789, 2005, 2006.
Manufacturer: Medical Technology Products Inc., Hungtington, New York
Recalled by: Manufacturer by telephone June 5-6, 1990. Firm
initiated recall ongoing.
Distribution: Nationwide, Mexico.
Quantity: 109 units were distributed.
Reason: The unit software was incorrectly programmed which
caused the word "RATE" instead of "TOTL" to be displayed
by the infusion pump when its Tamper Alarm feature is
activated by the unauthorized or unintentional change
of the "hundredths" total volume digital switch.
----
Class III -
Product: 3M Fletcher-Suit-Delcios Applicators, used in
intracavity treatment of cervical and/or uterine cancer,
Recall #Z-851-0
Code: All serial numbers.
Manufacturer: Basic Industries, New Brighton, Minnesota.
Recalled by: 3M Medical Device Division, St. Paul, Minnesota by
letter May 4, 1990. Firm initiated recall ongoing.
Distribution: Nationwide, international.
Quantity: 1,100 applicators were distributed.
-6-
Reason: The ovoids (egg-shaped enclosures into which the
cesium-137 sources are inserted) may become loose or
may detach from the ovoid handles of the applicators.
----
Product: APO Cal Apolipoprotein Calibrator, an in-vitro diagnostic
product, Recall #Z-852-0.
Code: Lot #"M907129", Exp. date "1/31/91".
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California by telephone
and follow-up letter dated March 30, 1990. Firm
initiated recall ongoing.
Distribution: Illinois, Indiana, Kansas, Wisconsin, Florida,
International.
Quantity: 879 units were distributed.
Reason: The value assigned for the device is inaccurate,
which may cause an elevated recovery in control materials
and patient samples.
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