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SafetyAlerts
January 11, 2000

23 Pharmaceutical Ingredients Recalled by Meridian Chemical

Amarillo, TX (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Meridian Chemical and Equipment is recalling 23 active and inactive pharmaceutical ingredients because of packaging errors.

The recalled products were packaged on the same equipment as penicillin or cephalosporin products.

The pharmaceutical ingredients affected by this recall are:

A) Various pharmaceutical ingredients, repacked on the same day after penicillin products were repackaged in the same facility using common packing and labeling equipment:

1) Brompheniramine powder, 100 g units, antihistamine
Lot Number 98291211

2) Castor Oil, USP, 3840 mL and 500 mL, laxative
Lot Numbers 97280806 and 97280807

3) Choline Chloride FCC, 500 g and 1 kg, supplement
Lot Numbers 97280808 and 97280809

4) Chromium Picolinate (Picolinic Acid, Chromium Salt Powder), 122.5 mg Cr/g, 5 g, supplement
Lot Numbers 98250610 and MB0295

5) Ergononvine Maleate, USP, 5g, 200 g, & 350 g, uterine stimulan/migraine treatment
Lot Numbers 99230705, 99230709 and 99230710

6) Estriol, USP, micronized, 1 g, 5 g, 25 g, & 100 g, hormone replacement
Lot Number 99200813, 99200815, 99200816 and 99200817

7) Fluoxetine HCL, 7 g, 6 g, 10 g, & 20 g, antidepressant
Lot Numbers 97120808, 97120808 and 97120809

8) Glycerol Formal liquid, 3840 mL, solvent
Lot Number 98140511

9) Haloperiodol, USP, 1 g and 5 g, antipsychotic
Lot Numbers 98250611 and 98250612

10) Liver Extract, 100 g, supplement
Lot Number 98250607

11) Naltrexone Hydrochloride 25 g, opiate antagoist
Lot Number 98060306

12) Phentolamine Mesylate, USP, 500 mg, 1 g, alpha-blocker
Lot Numbers 99230703, 99230704 and S9230704

13) Progesterone USP, Micronized, 89 g, 100 g, 1 kg, 5kg, and 500 kg, hormone replacement
Lot Numbers 99072310, 99072311, 99072312, 99230713, 99200814 and S9200814

14) Riboflavin USP (Vitamin B12), 25 g and 100 g, supplement
Lot Numbers 98250608 and 98250609

15) Tetracaine, USP, 3.75 g, 5 g, and 25 g, topical anesthetic
Lot Numbers  98250604, 98250605 and 98250606

16) Trimethoprim, USP (non-micronized), 100 g, 500 g, and 1 kg, antibiotic.
Lot Numbers 98060307, 98060308, 98060309 and 99070104

B) Active and inactive pharmaceutical ingredients repacked on the same day after cephalosporin products were repackaged, in the same facility and using common packing and labeling equipment.

1) Cyclosporin A, USP, Powder, 500 mg and 1 g, antibiotic
Lot Numbers 98121005 and 98121006

2) Dermabase cream, 454 g, cream
Lot Number 8G6104

3) Dihydroergotamine Mesylate, USP, powder, 5 g, migraine treatment
Lot Number 98231111

4) Hydroxocobalamin, USP, (Vitamin B-12), 250 mg and 1 g, supplement
Lot Numbers 98121003 and 98121004

5) Ketoprofen, USP, powder, 100 g, anti-inflammatory
Lot Number 98231110

6) Progesterone, USP, micronized, powder, 25 g, hormone replacement
Lot Number 98231109

7) Reserpine, USP, powder, .91 g, 1 g, 5 g, hypertension.
Lot Numbers 98121007, 98121008 and 98121009

According to FDA, 340 containers were distributed nationwide.

This ongoing Class II recall was initiated by Raphah, Inc. by letters dated November 24 and 26, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-162/177-0

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.