JUNE 1999

JUNE 1999

WEEK ENDING JUNE 11

PRODUCT Rejuvamin PM Capsules (Gammadeoxytetronic Acid), OTC in packets of 4 units.
CODE All lot numbers
MANUFACTURER Tishcon Corporation, Westbury, New York (contract Manufacturer).
RECALLED BY Biocentrics, A Division of Unique Products Company, Brentwood, Tennessee
DISTRIBUTION Nationwide.
QUANTITY Approximately 150 cases (each case containing 24 boxes with 30 packets inside the box) were manufactured. All of the product was distributed except 5 boxes (150 packets).
REASON Product is an unapproved new drug.

PRODUCT Dilantin 30 mg Kapseals (Extended Phenytoin Sodium Capsules, USP), in bottles of 100. NDC N0071-0365-24.
CODE Lot #27458L EXP 6/00.
MANUFACTURER Warner Lambert Company, Morris Plains, New Jersey.
RECALLED BY Park Davis, Division of Warner Lambert Company, Morris Plains, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 36,376 units were distributed.
REASON Dissolution failure (at 3 month stability testing).

PRODUCT Indomethacin Extended Release Capsules, USP, 75 mg, packaged in 7, 10, 14, 20 and 30 capsule unit containers, Rx non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis, ankylosing spondylitis and rheumatoid arthritis, NDC #0258-3607- 01.
CODE Product #1518-0: lots 8230204, 8201099, 8161047, 8154080, 9048138, 9034225, 8266102, 8247110, 9076111, 9070061, 9050087Product #1518-1: lots 8166183, 8154081, 8258129, 8239032, 8253084, 8209090, 9006096, 8336136, 8335170, 8316110, 9096140, 9091075, 9084013, 9049091
Product #1518-2: 8303074, 8259121, 8247043, 8142062, 9085035, 9070002, 8355066, 8328097
Product #1518-3: 8237077, 8233057, 8230127, 8210077, 8341203, 8335171, 8327166, 8237157
Product #1518-6: lots 9068141, 9067119, 9039184, 8362154, 8308179, 8307158, 8280168, 8160142, 8147139.
MANUFACTURER Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY Allscripts, Inc., Libertyville, Illinois (repacker)
DISTRIBUTION Indiana, Illinois, California, Missouri, Pennsylvania, Wyoming, Iowa, Maine, Nevada, Ohio, Colorado, Washington State, Florida, Tennessee, Michigan, Connecticut.
QUANTITY 62 bottles of 30, 300 bottles of 7, 280 bottles of 14, 91 bottles of 20 and 124 bottles of 10 capsules were distributed. Firm estimates that less than 25% of the product remained on the market at time of recall initiation.
REASON Dissolution failure.

PRODUCT Trifluoperazine HCl Tablets, USP, a) 1mg, in 100 count bottles; b) 2mg, in 100 count bottles; c) and 5mg, in 100 and 500 count bottles; d) Fluphenazine HCl Tablets, USP, 1 mg, in 100 and 500 count bottles, Rx prescribed for the management of the manifestations of psychotic disorders and non-psychotic anxiety.
CODE
a-c) Strength Lot No NDC No. Size(Tabs) Exp Date
1 mg E132L 00378-2401-01 100 10/00
2 mg E131L 00378-2402-01 100 10/00
5 mg E128L 00378-2405-01 100 10/00
5 mg E128L 00378-2405-05 500 10/00
d) 1 mg E235E 00378-6004-01 100 08/00
00378-6004-05 500 08/00.
MANUFACTURER Mylan Pharmaceuticals, Inc., Morgantown, West Virginia.
DISTRIBUTION Nationwide.
QUANTITY a-c) Firm estimated that 14,392 bottles of 100 tablets, and 200 bottles of 500 tablets; d) 9,047 bottles of 100 and 960 bottles of 500 tablets remained on market at time of recall initiation.
REASON Subpotency (at 3 month stability).

PRODUCT Rx oral tablets in unit dose blister packages of 100 tablets, 10 strips of 10 tablets, indicated for the management of psychotic disorders:
a) Trifluoperazine Hydrochloride Tablets, USP, 1 mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-572-20
b) Trifluoperazine Hydrochloride Tablets, USP, 2 mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-573-20
c) Trifluoperazine Hydrochloride Tablets, USP, 5mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-574-20
d) Fluphenazine Hydrochloride Tablets, USP, 1 mg, in unit dose packages of 100 (10 strips of 10 tablets).NDC #51079-485-20.
CODE Lot numbers: a) 9A159; b) 9A160 and 9B358; c) 9A161 and 9C485; d) 8S844.
MANUFACTURER Mylan Pharmaceucticals, Inc., Morgantown, West Virginia.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker)
DISTRIBUTION Nationwide.
QUANTITY a) 100; b) 275; c) 374; d) 1,404 unit cartons were distributed; firm estimated that 40% of the products remained on the market at time of recall initiation.
REASON Subpotency (at 3 month stability).

WEEK ENDING JUNE 18

PRODUCT Liothyronine Sodium, USP, bulk powder in 1 and 5 gram containers, Rx for the treatment of hypothyroidism.
CODE 9802163, 971257, 9808168, and 9802133.
MANUFACTURER Gallipot, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide.
QUANTITY 2 5-g containers and 10 1-gallon containers were distributed.
REASON Product is Mislabeled - Actually contains Levothyroxine Sodium.

PRODUCT Bromocriptine Mesylate, USP, Rx used to reduce tumor size prior to performing
surgeries: a) Bromocriptine Mesylate Tablets 2.5 mg, in 30 and 100 count bottles, under the
Rosemont and Mylan labels; b) Bromocriptine Mesylate Capsules 5 mg, in 30 and 100 count
bottles under the Rosemont label.
CODE All lots within expiration date.
MANUFACTURER Lek Pharmaceutical and Chemical Company, Ljubijana, Slovenia.
RECALLED BY Lek, USA Englewood Cliffs, New Jersey
DISTRIBUTION Colorado.
QUANTITY a) 6,678,000 bottles; b) 881,000 bottles were distributed.
REASON Lack of assurance of bioequivalence.

PRODUCT Levothyroxine Sodium Tablets, Rx in bottles of 100 and 1000, used as a
replacement or supplemental therapy in patients with hypothyroidism and as a pituitary
TSH suppressant in the treatment or prevention of various types of euthyroid goiters:
a) 25 mcg (0.025mg); b) .50 mg (0.05mg); c) 150 mcg (.15mg); d) 300 mcg (.3mg)
CODE a) Levothyroxine Sodium 0.025mg Rx Tablets, lot #'s:
004097A, exp. 02/99 (NDC #0254-3911-28)
004097B, exp. 02/99 (NDC #0254-3911-28)
004097C, exp. 02/99 (NDC #0603-4192-32)
047117D, exp. 05/99 (NDC #0603-4192-32)
047117E, exp. 05/99 (NDC #0254-3911-38)
047117G, exp. 05/99 (NDC #0677-1648-01)
047117H, exp. 05/99 (NDC #0677-1648-10)
032127A, exp. 05/99 (NDC #0254-3911-28)
032127B, exp. 05/99 (NDC #0254-3911-38)
032127C, exp. 05/99 (NDC #0254-4192-21)
032127D, exp. 05/99 (NDC #0603-4192-32)
033127B, exp. 05/99 (NDC #0603-4192-21)
033127C, exp. 05/99 (NDC #0603-4192-32)
033127D, exp. 05/99 (NDC #0254-3911-28)
033127E, exp. 05/99 (NDC #0254-3911-38)
b) Levothyroxine Sodium 0.05mg Rx Tablets, lot #'s:
005097A, exp. 02/99 (NDC #0254-3912-38)
005097F, exp. 02/99 (NDC #0254-3912-38)
006097A, exp. 02/99 (NDC #0603-4193-32)
004127A, exp. 05/99 (NDC #0603-4193-21)
004127B, exp. 05/99 (NDC #0254-3912-28)
004127C, exp. 05/99 (NDC #0603-4193-32)
c) Levothyroxine Sodium 0.150mg Tablets, lot #'s:
044087A, exp. 07/99 (NDC #0603-4196-21)
044087B, exp. 07/99 (NDC #0254-3915-28)
044087C, exp. 07/99 (NDC #0677-0992-01)
044087D, exp. 07/99 (NDC #0254-3915-38)
044087E, exp. 07/99 (NDC #0603-4196-32)
d) Levothyroxine Sodium 0.3mg Rx Tablets, lot #'s:
017047C, exp. 03/99 (NDC #0254-3917-28)
017047D, exp. 03/99 (NDC #0254-3917-28)
017047F, exp. 03/99 (NDC #0254-3917-28)
017047G, exp. 03/99 (NDC #0603-4198-21)
017047B, exp. 03/99 (NDC #0603-3917-38).
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.
DISTRIBUTION Alabama.
QUANTITY
4800 bottles of Levothyroxine Sodium 0.025mg, lot #004097A.
6077 bottles of Levothyroxine Sodium 0.025mg, lot #004097B.
954 bottles of Levothyroxine Sodium 0.025mg, lot #004097C.
532 bottles of Levothyroxine Sodium 0.025mg, lot #047117D.
1369 bottles of Levothyroxine Sodium 0.025mg, lot #047117E.
1421 bottles of Levothyroxine Sodium 0.025mg, lot #047117G.
838 bottles of Levothyroxine Sodium 0.025mg, lot #047117H.
4192 bottles of Levothyroxine Sodium 0.025mg, lot #032127A.
1208 bottles of Levothyroxine Sodium 0.025mg, lot #032127B.
2772 bottles of Levothyroxine Sodium 0.025mg, lot #032127C.
984 bottles of Levothyroxine Sodium 0.025mg, lot #032127D.
2592 bottles of Levothyroxine Sodium 0.025mg, lot #033127B.
1800 bottles of Levothyroxine Sodium 0.025mg, lot #033127C.
2527 bottles of Levothyroxine Sodium 0.025mg, lot #033127D.
600 bottles of Levothyroxine Sodium 0.025mg, lot #033127E.
1179 bottles of Levothyroxine Sodium 0.05mg, lot #005097A.
804 bottles of Levothyroxine Sodium 0.05mg, lot #005097F.
3000 bottles of Levothyroxine Sodium 0.05mg, lot #006097A.
3192 bottles of Levothyroxine Sodium 0.05mg, lot #004127A.
9720 bottles of Levothyroxine Sodium 0.05mg, lot #004127B.
1074 bottles of Levothyroxine Sodium 0.05mg, lot #004127C.
652 bottles of Levothyroxine Sodium 0.3mg, lot #017047C.
1792 bottles of Levothyroxine Sodium 0.3mg, lot #017047D.
1440 bottles of Levothyroxine Sodium 0.3mg, lot #017047F.
1200 bottles of Levothyroxine Sodium 0.3mg, lot #017047G.
924 bottles of Levothyroxine Sodium 0.3mg, lot #017047B.
1407 bottles of Levothyroxine Sodium 0.150mg lot #044087A.
1784 bottles of Levothyroxine Sodium 0.150mg lot #044087B.
1195 bottles of Levothyroxine Sodium 0.150mg lot #044087C.
829 bottles of Levothyroxine Sodium 0.150mg lot #044087D.
589 bottles of Levothyroxine Sodium 0.150mg lot #044087E.
REASON Lack of assurance of potency through expiration date.

PRODUCT Lycall Cold Sore Ointment (Lysine/Camphor/Menthol), in 8 gram jars
CODE Lot #1541 EXP 23/01.
MANUFACTURER Caleb Laboratories, Inc., Minneapolis, Minnesota.
DISTRIBUTION Minnesota, Wisconsin, North Dakota, Colorado.
QUANTITY 924 jars were distributed.
REASON Lysine subpotency.

PRODUCT Rugby brand Calcium Carbonate Tablets, 10 gr (648 mg), in 1,000 tablet containers
CODE Lot #1795-8911 EXP 11/02.
MANUFACTURER Tischon Corporation, Salisbury, Maryland.
RECALLED BY Tishcon Corporation, Westbury, New York
DISTRIBUTION Georgia.
QUANTITY 1,005 bottles were distributed.
REASON Tablet mix-up - Bottles contain brewer's yeast tablets (light brown).

PRODUCT Acyclovir Tablets or Capsules, Rx used as an anti-viral medication for Herpes Simplex I:
a) 200 mg, in 100, 500 and 1,000 capsule bottles
b) 400 mg, Rx in 100, 500, and 1,000 tablet bottles
c) 800 mg, Rx in 100, 500, and 1,000 tablet bottles
Labels and NDC Numbers -- Schein Pharmaceuticals
0365-2692-01    100 capsules/200 mg
0364-2689-01    100 tablets/400 mg
0364-2689-05    500 tablets/400 mg
0364-2689-01    100 tablets/800 mg
Mylan Pharmaceutical Inc.
0378-1464-01    100 tablets/400 mg
0378-1468-01    100 tablets/800 mg
Par Pharmaceutical
49884-460-05    200 mg   500 capsules
49884-460-01                    100 capsules
49884-460-10                   1000 capsules
49884-487-01    400 mg   100 tablets
49884-487-05                    500 tablets
49884-487-10                   1000 tablets
49884-474-01    800 mg   100 tablets
49884-474-05                   500 tablets
49884-474-10                   1000 tablets
Cimetidine Tablets, used as a stomach acid reducer for patients with stomach ulcers
d) 200 mg, Rx and OTC, in 6,10, 12,18, 30, 50, 60, 90, and 100 count units
e) 300 mg, Rx in 100, 500, and 1,000 count bottles
f) 400 mg, Rx in 60, 100, 500, and 1,000 count bottles
g) 800 mg, Rx in 30, 100, and 250 count bottles.
Labels and NDC Numbers--Cimetidine 200 mg OTC
Firm Name                NDC#       Packaged Size
Eckerd Drug Company   19458-957-61   6 tablet blister
                      19458-957-62              18 tablet blister
                      19458-957-63              30 tablet blister
                      19458-957-64              60 tablet blister
Albertson's           41163-229-08    30 tablet blister
Equate                50606-229-08       30 tablet blister
Packaged by           50606-229-15 60 tablet blister
BI-MART                                         12 tablet blister      30 tablet blister
Western Family Foods, Inc.          12 tablet blister      30 tablet blister
Kaiser Permanente     00179-1308-30 30 tablet blister
                      00179-1308-90 90 tablet blister
Pharmacist Formula                  18 tablet blister
Marketed by:          (special 30 tablet blister for above)
Leiner Health Products, Inc.        30 tablet blister
                                                         50 tablet blister
VONS                     58828-229-08 30 tablet blister
Safeway Inc.         21130-229-08 30 tablet blister
Bulk shipping label
LEK Pharmaceutical and Chemical Co., d.d.
Ljubljana, Slovenia      60x6 coated tablet blister
                         60x6 tablets acid reducer
                         60x10 tablets acid reducer
                         60x10 coated tablets
Cimetidine 200 mg, RX
Rosemont     0832-0101-00 100 tablet bottles
Brightstone 62939-2111-1 100 tablet bottles
Schein       364-2591-01        100 tablet bottles
             0364-2591-01            100 tablet bottles
Martec       52555-708-01     100 tablet bottles
Qualitest    0603-2890-21     100 tablet bottles
URL          0677-1527-01       100 tablet bottles
Cimetidine 300 mg
Rosemont        0102-00 100 tablet bottles
                0832-0102-50 500 tablet bottles
                0832-0102-10 1000 tablet bottles
Brightstone     62939-2121-1 100 tablet bottles
Schein          0364-2592-01 100 tablet bottles
                0364-2592-05 500 tablet bottles
Martec          52555-709-01 100 tablet bottles
Apothecon       59772-0229-5 500 tablet bottles
Qualitest       0603-2891-28 500 tablet bottles
URL             0677-1528-01 100 tablet bottles
MOVA            55370-866-07 100 tablet bottles
Cimetidine 400 mg
Rosemont          0832-0103-06   60 tablet bottles
                  0832-0103-00 100 tablet bottles
                  0832-0103-50 500 tablet bottles
                  0832-0103-10 1000 tablet bottles
Brightstone       62939-2131-1 100 tablet bottles
Martec            52555-710-01 100 tablet bottles
Schein            0364-2593-01 100 tablet bottles
                  0364-2593-05 500 tablet bottles
URL               0677-1529-01 100 tablet bottles
                  0677-1529-05 500 tablet bottles
Novapharm         55953-436-40 100 tablet bottles
                  55953-436-70 500 tablet bottles
                  55953-436-80 1000 tablet bottles
Apothecon         59772-0230-3 100 tablet bottles
                  59772-0230-7 500 tablet bottles
Qualitest         0603-2892-28 500 tablet bottles
Cimetidine 800 mg
Rosemont        0832-0104-03   30 tablet bottles
                         0832-0104-00 100 tablet bottles
                         0832-0104-25 250 tablet bottles
Martec             52555-711-01 100 tablet bottles
Novapharm     55953-516-40 100 tablet bottles
Schein              0364-2594-01 100 tablet bottles
                          0364-2594-01
Brightstone     62939-2141-1 100 tablet bottles
Qualitest          0603-2893-21 100 tablet bottles
Apothecon      59772-0231-3 100 tablet bottles
                          59772-0231-4 250 tablet bottles.
CODE All lots within expiration date.
MANUFACTURER LEK Pharmaceutical and Chemical Company, Ljubljana, Slovenia.
RECALLED BY LEK, USA Englewood Cliffs, New Jersey
DISTRIBUTION New Jersey, New York, West Virginia.
QUANTITY Acyclovir Tablets --    37,464 bottles (Par) 430,284 bottles (Schein)
                       740,000 bottles (Mylan)
Acyclovir Capsules --   22,110 bottles (Par) 320,378 bottles (Schein)
Cimetidine Tablets --
200 mg OTC 11,026 blisters
200 mg RX   34,866 bottles
400 mg      307,813 bottles
800 mg      130,139 bottles were distributed.
REASON Lack of assurance of bioequivalence.

PRODUCT Astra 4% Citanest Forte with Epinephrine 1:200,000 (Prilocaine and Epinephrine
Injection, USP), in 1.8 mL cartons, indicated for the production of local anesthesia in dentistry.
NDC #0186-0540-14
CODE
Lot No.             Expiration Date
0540801072          Jul-99
0540801075          Jul-99
0540802017          Aug-99
0540803036          Sep-99
0540803044          Sep-99
0540803053          Sep-99
0540803072          Sep-99
0540803090          Sep-99
0540804018          Oct-99
0540804023          Oct-99
0540804037          Oct-99
0540804049          Oct-99
0540804054          Oct-99
0540804103          Oct-99
0540804107          Oct-99
0540805001          Nov-99
MANUFACTURER Astra Pharmaceuticals, L.P., Westborough, Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY 56,252 units were distributed
REASON Epinephrine subpotency (stability).

WEEK ENDING JUNE 25

PRODUCT Heparin Sodium 100 units/mL in 0.9% Sodium Chloride 5 mL fill in a 12 mL syringe.
The pre-filled heparin syringe is not intended to provide any therapeutic value.
CODE Lot numbers: 990202A and 990202B.
MANUFACTURER E.M.T.-Rx, Raleigh, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY 10,440 units were distributed.
REASON Mislabeling - Label states heparin concentration at 100 unit/mL while
manufacturing records indicate concentration at 10 units/mL.

PRODUCT Forest Levothroid Tablets, Rx indicated as replacement or substitution for diminished
or absent thyroid function:
a) LevothroidÆ Tablets, (Levothyroxine Sodium), 25 mcg, in 100 tablet bottles, NDC #0456-0320-01
b) LevothroidÆ Tablets, (Levothyroxine Sodium), 50 mcg, in 100 and 5,000 tablet bottles, NDC #0456-0321-51
c) LevothroidÆ Tablets, (Levothyroxine Sodium), 88 mcg, in 5,000 tablet bottles, NDC #0456-0329-01
d) LevothroidÆ Tablets, (Levothyroxine Sodium), 112 mcg, in 5,000 tablet bottles, NDC #0456-0330-01.
CODE Lot Numbers: a) 10981 and 1992; b) 109830, 109832, 109833 and 1995; c) 119829 and 119830; d) 119835 and 12988.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri
DISTRIBUTION Nationwide.
QUANTITY a) 20,123 100-tablet bottles; b) 7,356 5000-tablet bottles; c) 27,487 100-tablet bottles; d) 14,366 100-tablet bottles were distributed.
REASON Subpotency.

PRODUCT Miacalcin Nasal Spray (Calcitonin-Salmon), 200 IU/dose, in 2 mL vials, Rx for the treatment for postmenopausal osteoporosis in females greater than five years postmenopause, with low bone mass relative to healthy premenopausal females. NDC 0078-0311-90.
CODE
Lot #355A9473 EXP Date: December 2001
Lot #206Z4722 EXP Date - Aug / 2000
Lot #236Z5438 EXP Date - Oct / 2000
Lot #362B9718 EXP Date - Jan / 2002
Lot #362B9719 EXP Date - Jan / 2002
Lot #362B9971 EXP Date - Jan / 2002
Lot #200Z4716 EXP Date - Jul / 2000
Lot #201Z4717 EXP Date - Jul / 2000
Lot #202Z4718 EXP Date - Aug / 2000
Lot #203Z4719 EXP Date - Aug / 2000
Lot #204Z4720 EXP Date - Aug / 2000
Lot #205Z4721 EXP Date - Aug / 2000
Lot #207Z4723 EXP Date - Aug / 2000
Lot #208Z4724 EXP Date - Aug / 2000
Lot #210Z4725 EXP Date - Aug / 2000
Lot #213Z4726 EXP Date - Sep / 2000
Lot #214Z5066 EXP Date - Sep / 2000
Lot #215Z5067 EXP Date - Sep / 2000
Lot #216Z5068 EXP Date - Sep / 2000
Lot #323A6800 EXP Date - May / 2001
Lot #323A6802 EXP Date - May / 2001
Lot #323A6804 EXP Date - May / 2001
Lot #323A6806 EXP Date - May / 2001
Lot #323A6808 EXP Date - May / 2001
Lot #323A6810 EXP Date - May / 2001
Lot #324A6491 EXP Date - May / 2001
Lot #324A6494 EXP Date - May / 2001
Lot #324A6495 EXP Date - May / 2001
Lot #324A6611 EXP Date - May / 2001
Lot #324A6613 EXP Date - May / 2001
This recall covers all of the firms distributed product lots from 11/19/97 thru 05/20/99 identified under the same numbers NDC 0078-0311-90), and Lots: (Miacalcin Nasal Spray 200 IU Carton of 1's):
Lot #209Z2255 EXP Date - Aug / 2000
Lot #324A6483 EXP Date - May / 2001 -- and all of the firms distributed product lots identified under NDC 0078-9149-01.
MANUFACTURER Novartis Pharmaceuticals Corporation, Basel, Switzerland.
RECALLED BY Novartis Pharmaceuticals Corporation, Suffern, New York
DISTRIBUTION New Jersey, Tennessee, Indiana, Texas, Washington state, Oregon, California, Massachusetts, Illinois, Missouri, Florida, Puerto Rico, Vermont, North Dakota, New York, Michigan, Kentucky, Pennsylvania, New Mexico.
QUANTITY 131,837 cartons were distributed.
REASON Discoloration, low pH, and subpotency potential due to embedded ferrous contamination in a portion of glass vials used in production.

PRODUCT Fluocinolone Acetonide Topical Solution USP 0.01% in 60 mL bottles, Rx synthetic steroid used as an anti-inflammatory and anti-puritic agent, under the Zenith Goldline (NDC 0182-1564-68) and H.L. Moore (NDC 0839-6660-84). labels.
CODE Lot #K722 EXP 01/00.
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York.
DISTRIBUTION Ohio, California, Connecticut.
QUANTITY 1,632 bottles were distributed; firm estimated that less than 10 percent of the product remained on the market at time of recall initiation.
REASON Subpotency (stability).

PRODUCT
a)Hygroton Tablets (chlorthalidone, USP), 50 mg, in 100 tablet bottles, NDC 0075-0020-00;
b)Hygroton Tablets (chlorthalidone, USP), 25 mg, in 100 tablet bottles NDC 0075-0022-00. Products are Rx oral diuretics
CODE Lot Numbers: a) MN3117 EXP 6/30/00 and MN2528 EXP 9/30/00 MN2564 and MN2882 EXP 9/30/99; b) MN2523 EXP 8/31/99 and MN2428 EXP 8/31/99.
MANUFACTURER Rhone Poulenc Rorer, Manati, Puerto Rico.
RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 3,000 units of the 50 mg tablets and approximately 3,000 units of the 25 mg tablets remained on market at time of recall initiation.
REASON Dissolution failure.