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ZENITH RECALLING 36 DRUG PRODUCTS DISTRIBUTED AFTER JUNE 3 EFFECTIVE DATE OF REGULATORY AGREEMENT WITH FDA; RECALL INVOLVES 57 DOSAGE FORMS

Executive Summary

Zenith is recalling additional lots of 36 drug products that FDA says were distributed in violation of a June 3 regulatory agreement concerning the firm's unauthorized product reformulations. Under that agreement, Zenith said it would not distribute certain products that did not conform to formulation and manufacturing procedures approved by FDA. The June 3 agreement stated: "if the FDA determines that any lot of drugs has been manufactured and distributed by Zenith Labs after this date that does not conform to the formulation and manufacturing procedure as specified in approved NDA's, ANDA's or supplements, Zenith Laboratories will immediately recall the involved lot." Zenith said that in FDA's view the agreement precluded distribution of all such drugs as of June 3, regardless of when the drugs were manufactured. Zenith interpreted the agreement to mean that only those drugs manufactured after June 3 should not be distributed. In an Aug. 29 letter announcing the recall to its customers, Zenith stated: "In order to resolve outstanding regulatory issues with the FDA, Zenith Labs agreed in June 1986 not to distribute any lot of drugs manufactured after June 3 where formulation and manufacturing procedures varied from those contained in Zenith's approved applications for those products. Consequently, Zenith discontinued the distribution of any product manufactured after June 3 for which the formulation and/or manufacturing procedure varied from the approved." However, Zenith continued, FDA "has advised us that, in their view, shipments after June 3 of designated products manufactured prior to June 3 should also have been discontinued." The recall involves 57 dosage forms of 36 drugs. Zenith noted that only products shipped on or after June 3 are subject to the recall. Identical products shipped before June 3 are not being recalled. Zenith also had agreed to implement a stability testing program and complete a full validation of its drug manufacturing facilities, equipment and processes by the end of 1986. The June 3 agreement was reached after a series of agency inspections that found fault with Zenith's stability testing and documentation procedures and after the firm issued a Class III recall in May covering 63 lots of 12 products ("The Pink Sheet" June 2, T&G-9). One result of the prolonged dispute with FDA is the continuing delay of approvals for Zenith ANDAs. The firm has not received a drug approval since February and is understood to have several major ANDAs pending at FDA. They include generic versions of Searle's Calan (verapamil), Boehringer Ingelheim's Catapres (clonidine), MS&D's Triavil (perphenazine/amitriptyline), McNeil's Haldol (haloperidol), Lilly's Keflex (cephalexin) and Wyeth's Serax (oxazepam). In its Aug. 29 letter to customers, Zenith noted that "only products shipped on or after June 3, even if under the same lot numbers as products shipped after June 3, are not being recalled. If you are unable to Determine whether products were shipped to you before or after June 3, you may return any products bearing the referenced lot numbers." Zenith added that it will "issue a credit for both the materials and the shipping costs" incurred by customers as a result of the recall. ZENITH RECALLED DRUG PRODUCTS The following products are the subject of a recall issued by Zenith on Aug. 29. APAP with codeine chloramphenicol 250 mg, 500 mg chlordiazepoxide 5 mg, 25 mg chlorpropamide 100 mg, 250 mg chlorthalidone 25 mg, 50 mg conjugated estrogens .3 mg cyproheptadine 4 mg doxycycline hyclate 50 mg, 100 mg erythromycin 250 mg furosemide 20 mg, 40 mg H&H 25/25, 50/50 hydrochlorothiazide 50 mg hydroserpine #1, #2 hydroserpine plus hydroxyzine pamoate 25 mg, 50 mg isosorbide 2.5 mg, 10 mg meprobamate 200 mg, 400 mg methocarbamol 500 mg, 750 mg methocarbamol with aspirin methyclothiazide 5 mg phentermine HCI 30 mg phenytoin sodium 100 mg probenecid colchicine propoxyphene 65 mg propylthiouracil 50 mg quinidine 200 mg spironolactone 25 mg spironolactone with hydrochlorothiazide sulfinpyrazone 100 mg tetracycline HCl 250 mg thioridazine 10, 15, 25, 50, 100, 250 mg tolbutamide 500 mg trifluoperazine 1, 2, 5, 10 mg triprolidine HCl chloramphenicol 250 mg, 500 mg

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