21 C.F.R. § 7.49

Recall communications

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:

(1) That the product in question is subject to a recall.

(2) That further distribution or use of any remaining product should cease immediately.

(3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.

(4) Instructions regarding what to do with the product.

(b) Implementation. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: “drug [or food, biologic, etc.] recall [or correction]”. The letter and the envelope should be also marked: “urgent” for class I and class II recalls and, when appropriate, for class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner.

(i) Be brief and to the point;

(ii) Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;

(iii) Explain concisely the reason for the recall and the hazard involved, if any;

(iv) Provide specific instructions on what should be done with respect to the recalled products; and

(v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.

(2) The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, followup communications should be sent to those who fail to respond to the initial recall communication.

(d) Responsibility of recipient. Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with paragraphs (b) and (c) of this section.

Notes of Decisions

Cited in 4 cases (1 in the last 5 years), 1998–2021 · leading case: Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460 (D.N.J. 1998).

Sort: Relevance Newest Treatment

Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460 (D.N.J. 1998). · cites it 3× “” 30 21 C.F.R. § 7.49 (a). FDA regulations require that recall communications “[b]e brief and to the point [and][e]xplain concisely the reason for the recall” and “not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the…”

Bush v. Thoratec Corp., 13 F. Supp. 3d 554 (E.D. La. 2014). · cites it 2× “She argued that because the Food and Drug Administration (“FDA”) had no requirements for recall communications, warning requirements under state law were therefore consistent with federal law; or alternatively that Thoratec failed to comply with 21 C.F.R. § 7.49 , which provides…”

Clark v. Actavis Grp. HF, 567 F. Supp. 2d 711 (D.N.J. 2008). “See 21 C.F.R. § 7.49 (a) (“The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall.”

Industriens Pensionsforsikring v. Becton, Dickinson & Co. (D.N.J. 2021). “See 21 C.F.R. § 7.49 . corporate defendant cannot be held liable “absent a showing that at least one individual officer who made, or participated in the making of, a false or misleading statement did so with scienter.”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.