Current conditions in the pharmaceutical industry — an increasingly complex manufacturing process, stricter inspection procedures, and complex regulations — increase the likelihood that a pharmaceutical firm will make an error which will require a recall. This paper outlines Food and Drug Administration (FDA)-requested recalls as well as firm-initiated recalls of violative drugs. Recommendations for conducting effective recalls are provided.
Food & Drug Administrative Regulatory Procedures Manual, Part 5, Recall Procedures, 1988.
2.
21 U.S.C.A. §§331–332 (1972 & Supp. 1992).
3.
U.S. v. Odessa Union Warehouse, 833 F.2d 172 (9th Cir. 1987).
4.
21 U.S.C.A. §334 (1972 & Supp. 1992).
5.
U.S. v. 50 Boxes More or Less, 909 F.2d 24 (1st Cir. 1990).
6.
21 C.F.R. §211.1 et seq (April, 1992).
7.
21 U.S.C.A. §360h(a) (1992 Supp.).
8.
See United States v. Barr Laboratories, 1993 WL 25394, 1993 U.S. Dist. Lexis (D.N.J. 1993) United States v. K-N Enterprises, Inc., 461 F. Supp. 988 (N.D. Ill. 1978).
9.
21 C.F.R. §7.3 (April, 1992).
10.
21 C.F.R. §7.50 (April, 1992).
11.
21 C.F.R. §7.45(a) (April, 1992).
12.
21 C.F.R. §7.3(m) (April, 1992).
13.
21 C.F.R. §7.41 (April, 1992).
14.
21 C.F.R. §7.45(b) (April, 1992).
15.
21 C.F.R. § 7.46(a) (April 1992).
16.
See 21 C.F.R. §7.42 (April, 1992).
17.
21 C.F.R. §7.53 (April, 1992).
18.
21 C.F.R. § 7.55 (April, 1992).
19.
“Methods for Conducting Recall Effectiveness Checks” referenced in 21 C.F.R. §7.42(b)(3) (April, 1992).
20.
21 C.F.R. § 7.49 (April, 1992).
21.
See, Frederick v. Calbio Pharmaceuticals, 152 Cal. Rptr., 292 (Cal. App. 1979).
22.
Brown v. Syntex Laboratories, Inc., 755 F.2d 668 (8th Cir. 1985).
23.
See Commercial Union v. Glass Lined Pipe Co., 372 So.2d 1305 (Ala. 1979).
24.
See Thomas J. Lipton Inc. v. Liberty Mutual. 314 N.E.2d 37 (N.Y. App. 1974); Elco Ind. v. Liberty Mutual, 414 N.E. 2d 41 (Ill. App. 1980).
25.
International Hormones Inc. v. Safeco Insurance Company of America, 394 N.Y.S.2d 260 (1977).
26.
Beech Aircraft Corp. v. Rainey, 488 US 153 (1988).
27.
Ellis v. International Playtex, 745 F.2d 292 (4th Cir. 1984); Kehm v. Proctor and Gamble Manuf. Co., 724 F.2d 613 (8th Cir. 1983).
28.
See, Bizzle v. McKesson, 961 F.2d 719 (8th Cir. 1992).
29.
Chase v. General Motors corp., 856 F.2d 17 (4th Cir. 1988); Rule 801(d)(2), Federal Rules of Evidence.
30.
Bredice v. Doctors Hospital, Inc., 50 F.R.D. 249 (D.D.C. 1970), aff'd, 479 F.2d 920 (D.C.Cir. 1973); RickersonS., The Privilege of Self-Examination: How to Raise It and Use It, 58 Defense Coun. J. 504 (1991); Note, The Privilege of Critical Self-Examination, 96 Harv. L. Rev. 1083 (1983).
31.
Note, The Privilege of Critical Self-Examination, 96 Harv. L. Rev. 1083, 1086 (1983).
