Recalls / Class I
Class ID-0596-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
- Brand name
- Hydromorphone Hydrochloride
- Generic name
- Hydromorphone Hydrochloride
- Active ingredient
- Hydromorphone Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0703-0018, 0703-0110, 0703-0113
- FDA application
- ANDA078591
- Affected lot / code info
- Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.
Why it was recalled
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 53600 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-02-07
- FDA classified
- 2018-03-14
- Posted by FDA
- 2018-03-21
- Terminated
- 2019-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0596-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.