The firm assayed their reserve and/or complaint samples and found them to be within their specifications for Pontocaine HCI (9.5 - 10.5 mg/ml.). Mr. Dissinger stated that administration technique and/or patient resistance may have caused the complaints. DDR #20616 The defect report involved particulate matter in Neo-Synephrine 1% lot #0370. The firm received the complaint o/a 8/9/76 and proceeded to examine their reserve final pack of 0370. No particulate matter was noted by the firm. I reviewed the batch records for the product and found no problems, GMP or otherwise. I also reviewed and examined the existing reserve samples of Neo-Synephrine 1%. A total of 60 ampuls were examined; none contained particulate matter. A check of the firm's complaint files back to 12/75 on lleo-Synephrine 1% showed no similar complaints. GENEPAL STATEMENT: (cont'd) DDR #21377 Complaint concerned one ampul in a box of 25 which was not labeled with the brand name, generic name, lot number, or expiration date. The firm has written to the complainant requesting that they return the product in question (letter dated 9/16/76). As of 10/7/76 they have not received product in question. I reviewed the batch records for this lot, 115NF, and also the complaint files dating to 1/76. There were no indications in the batch records of any printing problems. There were no similar complaints on this product. The reserve sample of Demerol 10%, lot #115NF consisted of 100 ampuls. All of these ampuls were examined. None were found with printing problems. Mr. Dissinger could not explain a possible cause of the defect and said that the ampuls are 100% examined on the production line. No discussion with management was held and no FD-423 was issued. CHC/jmg 10/13/76 21-689 O 78-30 Charles M. Copperberg, Investigator #208 PRODUCT INVOLVED: SULFAMYLON-N, A VETERINARY RX TOPICAL ANTIBACTERIAL RECALLING FIRM: AF 5-019 FILE STERLING DRUG. STERLING DRUG WINTHROP LABS DIV, NY, NY THE RESPONSIBLE FIRM FOR THIS RECALL IS THE MYERSTOWN, PA FACILITY. AFTER RECEIVING A CONSUMER COMPLAIN OF A LEAKING CONTAINER, CODE THE BVM AHHE COMMITTEE HAS ADVISED THAT LONG RANGE USE OF THE PRODUCT COULD RESULT IN HAIR LOSS, SCARRING AND IN RARE CASES, POTENTIALLY WE ARE CLASSING THIS RECALL-AS CLASS II AND HAVE ASSIGNED RECALL NUMBER V-022-6.1 DOCUMENTS RELATING TO SQUIBB DRUG CO. A STATE UNIVERSITY MEDICAL CENTER 1542 TULANE AVENUE NEW ORLEANS LOUISIANA 70112 School of Medicine in New Orleans DEPARTMENT OF OBSTETRICS AND GYNECOLOGY June 26, 1973 Dr. Richard Crout Division of Epidemiology and Rockville, Maryland 20852 Dear Dr. Crout: At the recent American College of Obstetricians and Gynecologists Meeting in Bal Harbour, Florida, I had the opportunity to talk with physicians from F.D.A. regarding a subject which concerns me and they referred me to you. I have been concerned for some time about the use of drugs containing 19 Nor progestogens as tests of pregnancy. Although there is currently only one such drug marketed for this purpose in the U. S. (Gestest Squibb), many physicians undoubtedly employ the commoner oral contraceptive pills for this purpose as an equally effective substitute. Gestest contains Norethindrone Acetate, a drug which has been shown to masculinize the female fetus. (Fine, et al, Obstet. Gynec. 22:210, 1963). For this reason alone, it's use thus should not be allowed. The assumption is often made that since such drugs are given for short periods of time before the 16th week of pregnancy when external genitalia appears that the risk is small. The length of pregnancy often is uncertain when such drugs are given however. Furthermore the effects of both androgen and estrogens on later development of cyclic menses of the neonatal female rat is well known. The period corresponding to similar neurological stage of development in the human to that of the rat is unknown but probably occurs before the 20th week of gestation. Equally effective means of inducing menstruation as a pregnancy test are available in Oral Provera, which has proven to only rarely produce masculinization in the human and intramuscular Progesterone aqueous or in oil which has no masculinizing tendencies. |