PRODUCT: ERYTHROMYCIN STEARATE TABLETS, U.S.P. 500mg., DISTRIBUTED UNDER THE E.R. SQUIBB & SONS, INC., "ETHRIL '500'" LABEL. PACKAGED IN TWO'S, BLISTER-PACK, "MATCH-COVER" PHYSICIAN SAMPLES.

REASON FOR RECALL:

WITH PENICILLIN BY
QUALITY PER CFR 21

RECALLING FIRM:

SAMPLES OF THE LOT WERE FOUND TO BE CONTAMINATED NCAA. THE BATCH FAILED TO MEET STANDARDS OF #146,4 (B) (4).

E.R. SQUIBB & SONS, INC.
GEORGES ROAD

NEW BRUNSWICK, N.J. 08903

MILAN PHARMACEUTICALS, INC.
MORGANTOWN, WEST VIRGINIA

6.

7.

8A.

8B.

TOTAL AMOUNT MANUFACTURED OR RECEIVED: THIS LOT CONSISTED OF A TOTAL OF 43,200 UNITS OF TWO'S RELEASED FOR DISTRIBUTION BY SQUIB3.

GEOGRAPHIC AREA OF DISTRIBUTION:

RICO.

NATIONWIDE, INCLUDING PUERTO

TOTAL AMOUNT DISTRIBUTED AND DATES DISTRIBUTED: DISTRIBUTION
BEGAN ON 1/11/74 AND ENDED ON 3/26/74 TO PHYSICIANS AND DENTISTS
VIA SQUIBB SALES REPRESENTATIVES. AMOUNT DISTRIBUTED TOTALED
25,815 UNITS OF TWO's.

AMOUNT FROZEN AT ONSET OF RECALL: A TOTAL OF 17,385 PACKAGES OF
TWO'S WERE FROZEN THROUGHOUT THE FIRM'S DISTRIBUTION SYSTEM AND
BY SALES REPS ON 3/26/74.

9.

AMOUNT DISTRIBUTED RECOVERED:
RECOVERED FROM DISTRIBUTION.

1,063 UNITS OF TWO EACH WERE

10.

DISPOSITION OF RETURNS AND FROZEN STOCK: ON 8/15/74, 18,448 UNITS
OF TWO'S WERE DESTROYED BY "CENTERBLAST" DESTRUCTION AND THE
GROUND MATERIAL WAS THEN BURIED AT THE IMPORTICO DUMP LANDFILL
IN EDISON, N.J., AS A PER A LETTER DATED 8/15/74 FROM MR. GERALD
R. COVELLO, QUALITY ASSURANCE MANAGER FOR SQUIBB.

12.

WHEN BY WHOM, AND HOW PROBLEM PAS DISCOVERED AND FIRM NOTIFIED:
MILAN PHARMACEUTICALS, INC.
MORGANTOWN, WEST VIRGINIA, MANUMACTURED
BULK LOT OF TABLETS, LOT #91257, AND SHIPPED THEM TO E.R. SQUIDS,
NEW BRUNSWICK, N.J. SQUIBB PACKAGED THE TABLETS INTO PHYSICIAN
SAMPLES PACKACES OF TWO'S. THE BULK LOT WAS DECERTIFIED PER
W.T. ROBINSON/MILAN LETTER 3/27/74. SQUILB LEARNED OF THE RECALL
FROM MILAN ON 3/26/74.

MANNER IN WHICH FDA LEARNED OF PROBLEM: NCAA REPORTED CERTIFICATION
SAMPLES TO BE CONTAMINATED WITH PENICILLIN. ON 3/27474 SQUI3B
SENT A LETTER TO THEIR DETAIL MEN REQUESTING RETURN OF ALL
UNDISTRIBUTED SAMPLES. RECALL WAS EXTENDED BY SQUILE TO PHYSICIAN
LEVEL VIA THEIR LETTER OF 6/4/74 APTER SQUIBB DISCUSSION WITH
NCAA.

DATE RECALL CLOSED: WE CONSIDER THE DATE OF THE SQUIEB LETTER
(8/15/74) TO BE THE CLOSING DATE.

16.

NUMBER OF CONSIGNEES: APPROXIMATELY 2600 CONSIGNEES WHICH
INCLUDED PHYSICIANS AND DENTISTS.

19.

RESULTS OF CHECKS: 17 CONSIGNEES REMEMBER BEING NOTIFIED OF THE
RECALL BY THE FORMS SALES REPRESENTATIVE; 41 CONSIGNEES COULD
MEET REMEMBER BEING NOTIFIED OF THE RECALL BUT DID NOT HAVE ANY
OF THE RECALLED PRODUCT ON HAND; ONE DOCTOR HAD DIED; ANOTHER
HAD MOVED.

20.

NATURE OF VIOLATION/PROBLEM: THE EXACT NATURE OF THE VIOLATION
OR PROBLEM IN TERMS OF CCMPR'S CAN BE OBTAINED FROM BLT-DO, THR

HOME DISTRICT OF THE PRODUCT MANUFACTURER, SINCE BLT-DO CONDUCTED

AN INVESTICATION AT THE FIRM.

21.

ACTION FIRM IS TAKING FOR PREVENTION:

SAME AS 20.

23.

RELATIONSHIP OF THIS PROBLEM TO SIMILAR OR OTHER PRODUCTS/FIRM:
REPORTS OF PENICILLIN CONTAMINATION IS NOT UNCOMMON. WE ARL
AWARE OF SIMILAR OCCURRANCES IN THE INDUSTRY.

DISTRICT EVALUATION OF TOTAL RECALL EFFORT: THE FIRM RECOVERED
A SMALL PORTION OF THESE TABLETS. IN VIEW OF THE ESTIMATED RATE
OF USE (8,000 PACKAGES OF TWO'S PER MONTH) AND THE LENGTH OF TIME
(UP TO 6 MONTHS), THESE TABLETS WERE IN USE, WE CONSIDER THIS
RECALL SATISFACTORY. 4% OF TABLETS DISTRIBUTED WERE RETURNED.
SINCE THE NOTIFICATION TO THE PHYSICIANS AND DENTISTS WAS IN
PERSON BY THE SALES REPRESENTATIVE WE MAY ASSUME THAT IS THE
REASON FOR THE HIGH NUMBER OF EFFECTIVENESS CHECKS WHICH REPORTED
THAT THE CONSIGNEE HAD NOT BEEN NOTIFIED.

24. DISTRICT FOLLOW-UP: FIRM IS TO BE INSPECTED IN THE NEAR FUTURE.

Squibb

'AF 9.561

DEC 30 1374

FILE

Quentin D. Stanle

133 North Fourth

Klamath Falls, Oregon 97001

Dear Kr. Steele:

This is in reply to your Pecember 4, 1974 letter concerning Nycoloj.

The Food and Drug Administration dens het normally perform studies en dras under its surveillance, and we have porformed ron. on Tusolos. We are sure of reports that the topical use of gorycin has bran associated with dualness. These reports are rare. Reorycin is one of the ce monents of livcoleg due ve have no reports of any cases of deafness associated with the use of youlog itself.

MEMO OF (TELEPHONE) CONVERSATION

SUBJECT Request for Cancellation of Halog DATE February 21, 1975 (halcinonide cream 0-1%) Campaign

TELEPHONE

PERSONAL

INITIATED BY:

A. F.

9-561

ΓΙ

NAMES:

and

Norman W. Lavy, M.D.,DirectRegulatory Affairs, Squibb
C.C. Evans, M.D., Div. of Anti-Infective Drug Products, BD
Dr. Peter H. Rheinstein, Director, Div. of Drug Advertising
T.W. Cavanaugh, COS, Division of Drug Advertising

SUMMARY OF SUBSTANCE OF CONTACT

Dr. Lavy was called and specific reference was made to the subject campaign represented by journal ads 354-019; 354-021; 355-005; and brochures 354-005; 354-007; 354-006; 354-015 submitted with FD Form 2253 dated 1/21/75, pursuant to 21 CFR 310.300 (b)(3).

Dr. Rheinstein told Dr. Lavy that the material was graphically
misleading in that only the superior" figures were presented
on a colored graph while relegating to a footnote the
preponderance of cases which showed no comparative difference
between Halog and Betamethasone 0,1% cream. The promotional
copy also features a track and field" motif with such
headlines as "Higher...". "Faster", "Broadly effective...",
in addition to such themes as "New, not just to be different
new to be better". Moreover, the clinical before and after
comparison pictures were, according to Dr. Evans who reviewed
the NDA prior to approval, not representative of the typical
cases, tending to misleadingly demonstrate the superiority
of Halog.

Dr. Evans said that the implied and stated better results with Halog over Betamethasone 0.15 cream (Valisone CreamSchering) were not the case. Dr. Evans stated that the campaign is "one-sided, inaccurate, and definitely misleading."

Dr. Rheinstein said that WC were calling to request cancellation because that the story was not presented accurately,

particularly graphically.

Dr. Lavy said he did not have the material in front of him,
but he believed it was justified to present only the
"differences" to provide a basis for a choice with
"other things being equal."