Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/ 5 Jan 2023 / Class III

Recall due to mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Levofloxacin Tablets, USP 500 mg; 50 count bottles, (10052 bottles)

Manufactured for: Macleods Pharma USA, Inc.Princeton, NJ 08540;

Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC: 33342-022-08

The Firm had at least two types of debossing for the Levofloxacin 500mg tablets approved under ANDA 200839. The product is marketed by various marketers under different NDC numbers. ML63 is approved debossing for Levofloxacin 500mg tablets with NDC number 33342-022-08. T5 is approved debossing for Levofloxacin 500mg tablets with different NDC number (e.g. 333-532-31).

When Firm’s have same generic product but has different debossing and NDC numbers for different clients, due to market requirements etc, good practice is to have separate Product Item codes at intermediate stage (Compressed tablet) and final packed stage (finished good) with associated Bill of Materials for each different debossed Items. In electronic inventory management systems like SAP, this help in maintaining segregation and traceability, quantity reconciliations.

When same generic product is compressed / packed as different Items (SKUs) different debossing / NDC numbers it is typical to run the production in campaign – to avoid elaborate product change over cleaning, as there is no cross contamination risks. Nevertheless there should be comprehensive Line clearance checks when moving from one Item (1) with specific debossing to another Item (2) with a different debossing. In a compression Line it should ensure that all previous “Item” and related material are removed before compression starts for the next Item with a different debossing. (check points should include but not limited to: all tablet containers, punches of the previous “item”). Such Line clearance procedures should be handled with same seriousness as for a Product change over.

Similarly in packing, when packing of same “ generic product” but with different debossing / NDC numbers (Items) is scheduled one after another, Line clearance should ensure that all previous “Item” and related material are removed before packing starts for a different Item, with different debossing. (check points should include but not limited to: all tablet containers, primary and secondary packing materials, packaging inserts).

Firms should also look at whether there is potential for any carry over of previous item to next item in a reduced change over cleaning procedure (when changing from one item (1) to another item (2) of same generic product). Are there pockets in the machines and equipment where previous item can remain during change overs (hoppers, channels, chutes and so on). Include specific checkpoints for the same in change over cleaning procedure /checklists.

When companies have same generic product with different debossing (items), while issuing / picking tablet with specific debossing for packing, due to mix up one or more containers of bulk tablets with different debossing may be picked.  This can lead to some tablets of a wrong item being packed along with in a batch of specific item. The packs with wrong tablets may not be picked up during sampling  / QC testing, especially if the batch sizes are large.

• To avoid such occurrence several check points should be in place:

• While issuing / picking bulk tablets to production lines for packing, there should be  adequate checks by production as well as QA. The checks should be against a checklist and each container of the bulk tablets picked, their labels should be checked and recorded. The recording should include item code, batch number of the tablets, drum /container number.
• If bulk tablets are being moved to a day store or holding area pending packing, there should be adequate segregation between materials for different batch numbers.
• There should be 100% reconciliation of the bulk tablet containers of each item issued for packing, after each dispensing activity; it should be recorded.
• The dispensed labels should be checked and reconciled after packing and recorded. This can help identify any mix up before the product leaves the company premises and batch can be stopped from distribution
• QR codes (2 dimensional code) with scanner may be considered for labelling of bulk intermediates (e.g different compressed tablet items). Each drum of bulk tablets issued for packing can be scanned and reconciled. This can prevent wrong product code from being issued / picked for packing.

QC testing procedures should include testing for Description and Identification including debossing both at bulk tablet stage (Intermediate) as well as finished good stage for each item.

• Recall of the batch(es) as it will be confusing for the patients, medical professionals, doctors. 
• Investigate and establish the actual root cause(s). Perform Impact assessment to see whether more batches / product could be similarly impacted. If there are more batches impacted, initiate recall actions (if already distributed) or stop further distribution.
• Review the systems and procedures to prevent such mix ups. Implement corrective measures including the points discussed above (What companies should have in place..).