FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

There is yet another apparent quality-control problem in the generic drug manufacturer sector.  This one involves Sandoz, the generic drug unit of Novartis AG (NVS), and its metoprolol succinate ER tablets, which is a generic form of AstraZeneca's Toprol XL.

An August 26, 2008 Reuters article, "UPDATE 1-US warns Novartis generic unit on plant problems", provided this information from an FDA letter about the problems found by inspectors at a North Carolina Sandoz manufacturing site:

"We question the continued distribution of this product until better process controls are implemented and process validation is completed," the FDA letter said.

"We are also concerned that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations," the agency said.

Novartis sought to downplay this August 2008 FDA warning letter to Sandoz, according to the August 26 Reuters article:

Novartis spokesman Eric Althoff said the FDA's concerns were "primarily about documentation and validation."

"We are working together with the FDA to solve the problem," he said.

It is unclear as of August 26 whether Sandoz will cease distribution of its metoprolol succinate ER tablets (generic Toprol XL) and/or issue a recall of this medication.  We will be watching for these possible related developments.

In addition, we will post a link to the Sandoz warning letter regarding its metoprolol succinate ER tablets (generic Toprol XL) when this letter is available on the FDA web site.

P.S.  This August 12, 2008 FDA Warning Letter (08-ATL-13) concerns the Sandoz manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina.  (8/26/08)

Comments

[Phil Church]

I was switched to the Sandoz drug about a month ago and about two weeks later started experiencing light headedness. Doc can't find any reason for that but I am suspicious. Anyone else notice any symptoms?

[Tom Lamb]

Millie:

I appreciate you providing us this insight about the Sandoz metoprolol pill recall.

There has been no information from Sandoz nor the FDA since we first learned in late August about the manufacturing problems at the Wilson facility.

I do not know if this apparent pill defect has a safety consequence associated with it.

If you or someone else can send me a copy of any letter received from their pharmacy, Sandoz, or their agent who will be collecting the pills for them, I would welcome the opportunity to review it and learn more about the situation.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Millie S.]

Today when I tried to refill my Metaprolol, I found I could only get the larger sized generic - that is how I found out about this
recall issue. Rite Aid pharmacist told me that I should be receiving a letter in the mail with an address on where to send the balance of the pills for a refund. I called my cardio DR and had him issue a script for brand specific drug instead. I had been feel great at the end of 2007 and have been feeling poorly most of this year - I'm wondering now if this pill was a factor.

[Tom Lamb]

William:

I have not seen any recall notice for these metoprolol succinate ER tablets by Sandoz (Novartis), so I do not know if there is any safety aspect to it.

As stated in the article, there were quality-control issues that the FDA identified, and when you are dealing with a prescription drug one would imagine that making an "out-of-specification" pill could cause dangers for the patient taking it.

If you or someone else could send me a copy of any Sandoz metoprolol succinate ER tablets recall notice they have received, I would appreciate the opportunity to review it.

I hope you keep reading Drug Injury Watch.

Tom Lamb

[William Roberts]

I have benn taking this drug for about a year and am just now finding out about the recall, How could this drug negatively affect me? The phammacy where I trade had little or no info regarding this except that they were replacing it with the same drug made by ETHEX. These pills are much larger than the former ones and I would have difficulty in swallowing them. Any sugestions?

[Tom Lamb]

Mike:

The nature of the manufacturing problem at this NC Sandoz plant remains unclear, still. As such, I cannot tell you whether there is any safety aspect to it.

You should speak to your doctor and/or pharmacist if you are concerned about your current or future supply of metoprolol succinate ER tablets (generic Toprol XL).

Thanks for reading Drug Injury Watch.

Tom Lamb

[Mike Gordon]

I have been on Metoprolol Succ ER for 2 1/2 years. Should I be concerned?