William Clarke Wescoe, M.D.

Chairman of the Board

and Chief Executive Officer

Sterling Drug, Inc.

90 Park Avenue

New York, NY 10016

Dear Dr. Wescoe:

AFF S

5-017 FILE

APR 21 1976

I am pleased to know that you will serve as a member of the
Food and Drug Administration National Advisory Food and Drug
Committee for a term commencing immediately and ending
September 30, 1978.

Meetings of the Committee are usually held three times a year
in Rockville, Maryland, for one or two days. Compensation is
allowable at the rate of $120.00 per day for tire spent at
meetings. In addition, reimbursement is made for travel expenses
and a per diem is allowed. Details of travel arrangements will
be forwarded in sufficient time for your attendance at the next
meeting.

The enclosed "General Information" sheet provides background on
the forms required to complete your appointment.

I realize there are many pressing demands upon your time and
appreciate your willingness to help us with the work of this
important Committee.

Sterling Drug, Inc.
Myerstown, PA 17067
4/21,22,23/76

SUMMARY OF FINDINGS

This inspection wes conducted for the purpose of covering three assignments:

#2

+3

76-450, INX #0991530 from PK-2560 requesting a sample of Bayer Aspirin, 5 grein tablets, lot 52104 which may have become conLeminated by "moth balls" while stored in an Atlanta, GA wholesaler's warehouse..

76-Vä, beso dated 2/23/76 from District PS8 Coordinator assipain ten Drug Product Defect Reports for coverage.

76-406, medo dated 3/17/76 from liFD-333 requesting specific data on the product bronkopeter.

Also

On 4/21/76, PFD-452 and Credentials were presented to br. John E. Gardner, Jr., Director of Control. Dr. Gardaer directed copying of material requested and attached as exhibits, and answered the sajurity of questions. present during the inspection were: Clement P. Kapinsky, Quality Assurance Coordinator, and John Leidich, Assistant Supervisor. It was noted that Dr. Gardner frequently called Sterling's Sew York Office before releasing information.

1- Bayer Aspirin, Lot 52104

khen I asked Dr. Gardner if sey of the returns of this product were available for sampling, Dr. Gardner replied that the samples had been run at SterlingWinthrop Research Institute in Rensselaer, NY and that nothing had been done at Syerstown and no samples were available there. It was later detersined that a sample of lot 5F104 could be obtained at Rensselaer. 1 asked br. Gardner if it would be possible to obtain a copy of the results of the fire's own analysis of the product. Dr. Gardner called the fira's new York Office and I participated in a conference call with Dr. Gardner and ar. Ken Klippel of the key York Office, Lr. Klippel stated that a variety of Sterling products had been stored directly next to a lot of potà bells by the wholesaler, Drugs Autual, Inc. in atlanta, GA. dr. klippel stated that lot 58164 was the only lot on which they received complainte, citroma other sizes end controls of Eayer vere similarly stored, r. Klippel stated that sicrogram quantities of naphthalene had been found in samples of reternel stuck using gas chromatotraphic analysis. ine results of analysis for vac tablet from each of three bottles of lot 3F134 were: 4,55, 3.55, and 4,05 micrograns aphthalene per tablet. ⠀r. Klippel stated that the firm's Le al Department preferred not to provide a copy of the analysis, however i later obtained a report fro. br. Gardner. All Glenbrook merebandise hɛd been pulled from the wholesaler on 2/25/75,"returned to their Atlante distribution center, and destroyed ûn. 3772/76;`

Dr. Gardner later obtained the following additional information requested, The wholesaler was unable to provide a list of specific customers, however retail stock was destroyed on the dates indicated by the firm's Gales Representatives at the two locations from which complaints nad been received:

Destroyed on 3/27/76 at Bokae's Pharmacy, Douglas, GA 31533 (Drug Product
Defect Report #19484) and on 2/26/76 et Avondale Pharsacy, 126 Avurdale
Road, Avondale Estates, CA 30002 (consumer returned bottle to pharmacy
and the pharadcy called Sterling).

I asked br. Gardner if there were any health hazard from the naphthalene contamination. Dr. Gardner said that he would check with the firm's Medical Department. On 4/22/76, Dr. Gardner stated that according to the fire's edical Department, there was absolutely no health hazard involved. I later checked the Merck Indez (Eighth Edition) which stated that naphthalere was formerly used cetically as an anthelafatic. Under veterinary use, the Merck Index states that naphthalene has been used as an intestinal antiseptic and vermicide. The dose listed for horses is 8-15 grams; for duys, 0.06-1.3 grasa.

Dr. Carover liter provided a copy of a taree pase inter-office newo from sterling-hintarop kesearch lustitute which lists the lots of products involved and the results of analysis. This is attached as cla Exhibit zi. This report contains the statement: "The Layer Aspirin packaged in plastic

bottles was contaminated with naphthalene, but the products packaged in plaas containers were not". Dr. Gardner stated that the plastic bottles were made of polystyrene plastic. The following is a list of the other products essayed:

Bayer Aspirin, Lot 15040, 100's

Bayer Aspirin, Lot 52075, 200's

Bayer Aspirin Decongestant Cold Tablets, Lot 13425 ✓

Bayer Children's Cold Tablets, Lot 24422

Bayer Children's Aspirin, Lut 50316

Phillip's Milk of Magnesis, Lot 5801 (2v oz, nottles)✓

Phillip's Zilk or tagnesia, Lot 5528 (4 oz. bottles) /

For hayer Froducts, products manufactures at Nyerstown are cosed with a number, a letter & 3 muters. Froducts from the Trenton, kd plaat are coded vita a letter followed by four pumbers,

See Exhibit 1 for the essay method and results. un 4/30/76, I called ox. 6. D'Angelo, brl-333, and gave him a brief summary of this information.

2- Drug Product Defect Reports

Tes Drug Product Defect exports were covered ouring this inspection.
Gardner provided this information. The first niae Defect reports covered

ur.

refer to prutkameter:

Brug Product Defect Reports (cont'd)

BP1-5 $18244, 11-26-75, Lot 317552, 10 ml.
Problem: hase of valve leaks.

Fire's follow-Up:

A sample of two units was received. The first unit had less then 1 1.
of solution left, which ves an insuficient mount to evaluate the
functioning ability of the valve. The second unit contained about 3 el.
and hed a dirty actuator in which the vent hole was clogged. This unit
also had a side-of-stez defect which was not improved by a clean actuster.
(See Elk Exhibit #2, page 2 for copy of firm's letter detailing results,)

DPUR 718772, 1/22/76, Lut 8095kJ, 20 ml.
Problem: Container leaks,

Fire's Follow-Up:

The return sample consisted of one unit of 20 ul. ercakoseter (contrat #507187). This unit contained approximately 3x1, of solution and tee vent hold was clogged with residue. Laminatios revealed a side-vi-stei defect which was not improved with the usage of a clean actuator. (Spr Eix exhibit #2, page el, for copy of fin's letter detailing resalts,)

3. bpha #13295, 12/3/75, Luts 8059NV, 903714, 517598

4.

Problem: Containers lesk areund stem when attempting to use then,
Firm's follow-up:

The firs has received the Defect keport and nas requested a sample from the cumplainant.

DELA 218263, 11/13/75, Lot 807187, 20 al.

Problem: Spray iron bottos of valve.
Fire's Follow-up:

The returned esaples consisted of two units of 20 td. bronkaneter, The first unit (control 280593V) contained approxizately 3 ml, of solution when received. Upun exemization, a side-ul-sten driect was discovered which was not improved with the usage of a clean actuator. The second unit (control zaw7lik) contained approximately lo ml. ot solution when receives. Ixacination revealed a ridervi‐stes defect which was not improved with the usage of a cleen actuntur. (Tee 21% handbit wi, page #3, for copy of fira's letter detailing results.)

SUMMARY OF FINDINGS (cont'd)

12 - Drug Product befect Seports (cont'd)

3. DPUR #12176, 11/21/75, Lot 8029m, 20 1.

Problems:

Two units received as lesters and only partially full.
The third unit was returned by a patient who reported that
it exploded right siter she set it on her dresser.

Fire's Follow-Up:

The fire has received the Drug Product Defect feport end has requested a comple from the complainant.

6. BPDS #1:522, 12/23/75, Let 50712F, 20 1.

Problem: Liquid leaks out the back of the dispenser when sprayed.
Fire's Follow-Up:

Firm is aware of the Defect Report and has requested a sgaple from the complainant,

7. CPDR 18532, 12/29/75, Lot 8071KF, 20 ml.

Problem: Lessere at the base of the stem with 4 units from the same lot. Fire's Follower:

firm is aware of the Defect heport ene has requested a sample from the complainant, however the sample has not yet been received.

8. POR #18440, 12/15/75, Lot 2071be, 20 1.

Probles: Unit leaks around the base of the ster when inverted per

instructions.

Fira's Follow-up:

Ine returned sample consisted of 1 unit of control +50718? containing approximately 3 al. of solution and equipped with a dirty actuator when received. Examination of the vult revealed a sice-of-stem detect which was not improved with a cleap actuator, (her IE bxninit 2, page 14, for copy of tire's letter detading results,)

9. Urol. 18409, 12/11/75, Lot 507138 (all three bottles), 20 1, Probler: Caits co not aprey.

Hira's Follow-Up:

The returned sample consisted of two units of control 507158. unit contained approximately lo el. of solution and was equipped with a dirty actuator when received. animation of the unit reveried a slight side-of-stem defect which was improved with the usa,e of a clean actuator. The second unit contaired approxivately 19 1. of solution when received. Examination of the unit revealed a side-v1-step defect which was not i proved with the Lɛage of & clean actuator. (tee bli. Exhibit yà, pane #5, for copy of lir's letter detailing results.)