RECALL MD, DC, VA -PENICILLIN CONTAMINATION

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SafetyAlerts

February 12, 2002

Pharmaceutical Distribution Services Has Recalled Various Tablet and Capsule

Dosage Form Drug Products

(SafetyAlerts) - The Food and Drug Administration (FDA) released the

following information.

PRODUCT

Various tablet and capsule dosage form drug products, repackaged into plastic

amber pharmacy vials and unit dose blister packs of varying sizes/counts,

labeled with brand or generic names, strength, lot number, expiration date,

manufacturer, National Drug Codes (NDC) and name of repacker of the products

(PDS),

Recall # D-107-2/D-190-2.

PRODUCT                                     RECALL NUMBER

ACETAMINOPHEN 325 mg tablets-------------------D-107-2

AMOXICILLIN 500 mg capsules------------------------D-108-2

ALLEGRA-D (FEXOFENADINE/PSEUDOEPHEDRINE    HCL) 60mg/120mg

tablets-------------------------------D-109-2

ASPIRIN EC 325 mg tablets----------------------------D-110-2

ASPIRIN EC 81 mg tablets------------------------------D-111-2

ATENOLOL 50 mg tablets-------------------------------D-112-2

BAYCOL (CERIVASTATIN SOD)

0.3 mg tablets------------------------------------------------D-113-2

BAYCOL (CERIVASTATIN SODIUM)

0.4 mg tablets-------------------------------------------------D-114-2

BENZONATATE 100mg capsules---------------------D-115-2

CALCIUM 500 mg (OYSCO) tablets------------------D-116-2

CALCIUM 500 mg (OYST-CAL) tablets--------------D-117-2

CARDURA (DOXAZOSIN MESYLATE)

2 mg tablets---------------------------------------------------D-118-2

CELEXA (CITALOPRAM HBr) 20 mg tablets------D-119-2

CEPHALEXIN 250 mg capsules-----------------------D-120-2

CIPROFLOXACIN HCL 500 mg tablets--------------D-121-2

CLARITIN (Loratidine) 10 mg tablets------------------D-122-2

CYCLOBENZAPRINE HCL 10 mg tablets----------D-123-2

DE-CONGESTINE (CHLORPHEN. MALEATE 8mg/ PSEUDOEPHEDRINE 120mg)

capsules-----------D-124-2

DECONSAL II (PSEUDOEPHEDRINE AND GUAIFENESIN) 60 mg/600mg

tablets---------------D-125-2

DIPHENHYDRAMINE HCL 25 mg capsules-------D-126-2

DOCUSATE SODIUM 100 mg capsules------------D-127-2

DOCUSATE SODIUM 100 mg gel capsules-------D-128-2

DOXYCYCLINE 100 mg capsules---------------------D-129-2

ERYTHROMYCIN 250 mg tablets---------------------D-130-2

FOLIC ACID 1 mg tablets--------------------------------D-131-2

FUROSEMIDE 20 mg tablets---------------------------D-132-2

FUROSEMIDE 40 mg tablets---------------------------D-133-2

GLUCOPHAGE (METFORMIN HCL)

500 mg tablets------------------------------------------------D-134-2

GUAIFENESIN LA 600 mg capsules-----------------D-135-2

GUAIFENEX PSE 600 mg/60mg capsules---------D-136-2

HYDROCHLOROTHIAZIDE 25 mg capsules-------D-137-2

HYDROXYZINE HCL 25 mg tablets-------------------D-138-2

HYTRIN (TERAZOCIN) 2 mg capsules---------------D-139-2

HYTRIN (TERAZOCIN) 5 mg capsules---------------D-140-2

IBUPROFEN 400 mg tablets----------------------------D-141-2

IBUPROFEN (MOTRIN) 800 mg tablets-------------D-142-2

ISONIAZID 300 mg tablets------------------------------- D-143-2

K-DUR (KCl) 20 mEq tablets----------------------------D-144-2

CEPHALEXIN (KEFLEX) 250 mg capsules------- -D-145-2

KLOR-CON (KCl) 10mEq (750 mg) tablets---------D-146-2

LEVAQUIN (LEVOFLOXACIN) 500 mg tablets----D-147-2

LEVOTHROID .1 mg tablets-----------------------------D-148-2

MACROBID (NITROFURANTOIN)

100 mg capsules---------------------------------------------D-149-2

METHOCARBAMOL 500 mg tablets-----------------D-150-2

METRONIDAZOLE 250 mg tablets--------------------D-151-2

MOTRIN (IBUPROFEN) 600 mg tablets-------------D-152-2

MULTI-VITAMINS Tablets---------------------------------D-153-2

NAPROSYN 500 mg tablets-----------------------------D-154-2

NAPROXEN 500 mg tablets-----------------------------D-155-2

NORVASC (Amlodipine Besylate) 5 mg tablets--D-156-2

NORVASC (Amlodipine Besylate) 10mg tablets-D-157-2

PHENAZOPYRIDINE HCL 100 mg tablets---------D-158-2

PLENDIL (FELODIPINE) 5 mg tablets---------------D-159-2

POTASSIUM CHLORIDE 10mEq capsules--------D-160-2

PREMARIN .3 mg tablets--------------------------------D-161-2

PREMARIN .625 mg tablets----------------------------D-162-2

PRILOSEC (OMEPRAZOLE) 20 mg capsules---D-163-2

PROMETHAZINE 25 mg tablets-----------------------D-164-2

PROVERA 2.5 mg tablets-------------------------------D-165-2

PROZAC (FLUOXETINE) 20 mg capsules---------D-166-2

PSEUDOEPHEDRINE HCL 30 mg tablets--------D-167-2

PSEUDOEPHEDRINE HCL 60 mg tablets---------D-168-2

Q-BID LA (GUAIFENESIN LA) 600 mg tablets----D-169-2

RANITIDINE 150 mg tablets------------------------------D-170-2

SULFAMETHOXAZOLE/TRIMETHOPRIM

800/160 MG tablets-----------------------------------------D-171-2

SYNTHROID (LEVOTHYROXINE)

0.05 mg tablets-----------------------------------------------D-172-2

SYNTHROID (LEVOTHYROXINE)

 0.075 mg tablets--------------------------------------------D-173-2

SYNTHROID (LEVOTHYROXINE)

0.1 mg tablets-------------------------------------------------D-174-2

SYNTHROID (LEVOTHYROXINE)

0.125 mg tablets---------------------------------------------D-175-2

TRIAMTERENE AND HYDRO-CHLORTHIAZIDE(MAXIDE)

75 mg/50 mg tablets----------------------------------------D-176-2

TRIMOX (AMOXICILLIN) 250 mg tablets-------------D-177-2

TYLENOL 325 mg tablets---------------------------------D-178-2

VIAGRA 100 mg tablets-----------------------------------D-179-2

VITAMIN E 400 mg SOFTGEL capsules------------D-180-2

VERAPAMIL 240 mg tablets----------------------------D-181-2

ZESTRIL (LISINOPRIL) 5 mg tablets------------------D-182-2

ZESTRIL (LISINOPRIL) 10 mg tablets----------------D-183-2

ZESTRIL (LISINOPRIL) 20 mg tablets----------------D-184-2

ZESTRIL (LISINOPRIL) 40 mg tablets----------------D-185-2

ZOCOR (SIMVASTATIN) 10 mg tablets-------------D-186-2

Z0COR (SIMVASTATIN) 20 mg tablets--------------D-187-2

ZOCOR (SIMVASTATIN) 40 mg tablets-------------D-188-2

ZOLOFT (SERTRALINE) 100 mg tablets------------D-189-2

ZYRTEC 10 mg tablets------------------------------------D-190-2

CODE

All expiration dates for the products distributed by the repacker since

startup of firm's operations in Aug 2000 through exp. date Nov 2002.

Expiration dates are printed on the label applied to vials and blister packs

and determined by the repacker based on one year from date

of repack.

RECALLING FIRM/MANUFACTURER

Pharmaceutical Distribution Services, Laurel, MD, by telephone and letter on

Dec. 5, 2001. Firm initiated recall is ongoing.

REASON

Contamination: Failure to test for penicillin in non-penicillin products due

to potential cross-contamination operations.

VOLUME OF PRODUCT IN COMMERCE

Unknown.

DISTRIBUTION

MD, DC and VA.