Drug recall

Diltiazem Hydrochloride Extended-Release Capsules, USP, 120 mg, 90 count bottle, Rx only, Manufactured for…

FDA recall event 29846 · Class III · Biovail Laboratories, Inc.

Key facts

Event ID 29846
Recall numbers D-045-5, D-046-5, D-047-5
Recalling firm Biovail Laboratories, Inc.
Product type Drugs
Products Diltiazem Hydrochloride Extended-Release Capsules, USP, 120 mg, 90 count bottle, Rx only, Manufactured for: Teva Pharmaceuticals, Sellersville, PA, Manufactured by: Biovail Corporation International…, Diltiazem Hydrochloride Extended-Release Capsules, USP, 180 mg, 90 count bottle, Rx only, Manufactured for Inwood Laboratories Inc., Inwood, NY, By Biovail Corporation, Mississauga, Ontario, Canada…, Diltiazem Hydrochloride Extended-Release Capsules, USP, 300 mg, 90 count bottle, Rx only, Manufactured for Inwood Laboratories Inc., Inwood, NY, By Biovail Corporation, Mississauga, Ontario, Canada…
Classification Class III
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Dissolution Failure
Initiation date Aug 11, 2004
City Carolina
Country United States
FEI number 2650179

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports

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