Food and Drug Administration, U.S. Department of Health and Human Services - June 19, 1987
Bill Grigg/David Duarte; (301) 443-4177

To ensure that condoms are meeting required standards, FDA has increased its inspection of manufacturers and processors of condoms and its programs of testing both domestic and foreign-made condoms. This was done when the agency urged manufacturers April 7 to inform consumers about how condoms should be used to maximize protection against sexually transmitted diseases, including AIDS.

This program included added attention to foreign manufacturers and imports. Since April, FDA has detained 15 shipments of condoms made by firms in Korea and four from Malaysia.

In FDA's April 7 letters to all U.S. condom manufacturers and distributors, the agency also urged manufacturers to ensure that their quality control processes are the best.

The industry standard requires, roughly, that no more than four condoms out of 1,000 leak. The condoms are tested by pouring 10 ounces of water in each and looking for leakage.

Following FDA's recent tests:

-- Schmid Laboratories of Little Falls, N.J., on June 8 voluntarily recalled from distribution channels one lot of latex condoms, Sheik Fetherlite with lot number 04-06-87. The recalled condoms are lubricated and have a reservoir tip. The recalled lot was distributed to 22 direct accounts throughout the United States but the firm reports almost all were still in transit or at wholesalers and are being recovered.

-- National Sanitary Labs of Lincolnwood, Ill., on May 8 voluntarily recalled Protex Contracept Plus brand latex condoms with spermicidal lubricant and reservoir, lot number 1661966S, expiration date 4-14-92. These were distributed to a wholesaler in California and two retailers in Indiana and Michigan. The firm estimates none of this particular lot remains on the market.

Following additional FDA tests, the firm on June 11 telephoned direct accounts to recall two additional lots:

(1) PROTEX AROUSE Condoms, Ribbed & Lubricated, reservoir end, coral tint, in 12-condom boxes with the retail code MFG 5 29 87.

(2) PROTEX SUNRISE Condoms in Blue Erotica, Emerald Haze and Golden Touch tints, lubricated with reservoir end, in three-condom and 12-condom boxes with codes MFG 4 28 87 and MFG 5 9 87, respectively.

-- Circle Rubber Corp. of Newark, N.J., after being informed June 11 of FDA test results, is voluntarily recalling SAXON and L'APPEL (the latter a private label with instructions in English and Spanish). They are lubricated ultra-thin, reservoir end, rubber condoms in cellophane envelopes with the code number 7485 on the packages and 487 on the envelopes. These were distributed in North Carolina and Illinois, to Adam & Eve distributors and the Johnston County Health Department (both in North Carolina) and to L'Appel Inc. of Northbrook, Ill., a vending machine operator.

Dr. Young emphasized that, because of FDA's increased testing, most of the defective lots could be intercepted before they reached individual purchasers.

He said that the agency and the industry will work to bring all the manufacturers up to "the high standard necessary to help markedly reduce the spread of AIDS and other sexually transmitted diseases."

Condoms are regulated by FDA under the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act.

NOTE: On June 9, the Health Protection Branch of the Canadian Department for National Health and Welfare announced that Julius Schmid Ltd. of Scarborough, Ontario, Canada, is recalling three lots of condoms because they did not meet the standard leakage test. The brands and lot numbers being recalled in Canada (not in the United States) are Ramses Sensitol (lubricated), lot PK32, EXP 0592; Ramses Nuform (lubricated), lot PK10, EXP 0592, and Sheik Fetherlite, lot PK10, EXP 0492. Canadian officials and the firm informed FDA that none of these lots was distributed in the United States.

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FD870601

SOURCE: Food and Drug Administration (FDA).

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