Drug recall

Doxepin Hydrochloride Oral Solution, USP (Concentrate), 10 mg/ml, 120 mL (4 fl.oz.) bottle, Rx only, Teva…

FDA recall event 30367 · Class III · Teva Pharmaceuticals USA

Key facts

Event ID 30367
Recall numbers D-075-5
Recalling firm Teva Pharmaceuticals USA
Product type Drugs
Products Doxepin Hydrochloride Oral Solution, USP (Concentrate), 10 mg/ml, 120 mL (4 fl.oz.) bottle, Rx only, Teva Pharmaceuticals, Sellersville, PA 18960 ***** NDC 0093-9612-12
Classification Class III
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Failed pH specification (6 month stability)
Initiation date Nov 3, 2004
City North Wales
Country United States
FEI number 3003092769

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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