Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Nifedipine Extended-Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
Affected NDC
47781-0368-01
Compare with the code on your package — it is the most precise check available.
Drug: Nifedipine Category: Blood Pressure Medication
- Recalling firm
- Alvogen, Inc
- NDC code
- 47781-368-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0627-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nifedipine recalls
See all
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
Nifedipine USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Other recalls by Alvogen, Inc
All 2017 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class I · High risk
Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
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