Strides recall Prednisolone tablets for mix up

Presence of foreign tablet – 2.5 mg tablet in a 20 mg tablets bottle of Prednisone Tablets. Product recalled : Prednisone Tablets USP, 20 mg, 100-count bottle.

Manufactured by: Strides Pharma Science Ltd., Bengaluru – 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

When companies have same “generic” product but in different strengths (for e.g – Prednisolone 1mg, 2.5mg, 5mg, 10mg,20mg,50mg), typically companies will do campaign production, ie a lower strength tablet followed by the higher strength. This has the advantage that the change over cleaning and line clearance when moving from lower strength to higher strength can be less intense ( e.g Type A less intense batch to batch cleaning rather than exhaustive Type B product change over cleaning). This is justified as there is no risk of cross contamination from a different active ingredient and product during such change overs. However in such change overs there exist a possibility of a a carry over of the previous product (lower strength) to next product (higher strength), from equipment parts / accessories (hopper, channel, chute and so on..). To prevent such mix up / carry over companies should have adequate measures:

·     A cleaning and verification procedure which covers all possible pockets / areas of such contamination / mix up. This should be based on a Risk assessment involving shop floor personnel reviewing all possible areas of contamination and mix up.

·      Elaborate checklist of all such difficult to reach / out of sight pockets. A less intense batch to batch cleaning, though do not raise concern of cross contamination, do have risk of such mix ups. In core manufacturing area ( granulation, blending etc) when moving from lower strength to higher strength can be a less intense batch change over cleaning procedure (Type A cleaning) as there is no cross contamination risk; but for compression suites and packing suites where mix up is a risk, product change over cleaning and line clearance between different strengths  should be  more thorough (Type B cleaning).

Through investigation establish probable root cause(s).

Map a list of all such product change overs – lower strength to higher strength. Review whether there are specific assignable causes for a mix up to happen only in specific batches [e.g change over cleaning was less than optimal in the case of specific batch(es)]. Accordingly, extent of recall can be decided. If there are assignable causes identified, extent of recall can be limited.

Perform risk assessment to evaluate possibility of similar mix up cases and evaluate need to extent recall.

Considering the impact of such mix up issues (with respect to extent of recalls, cost and effort and impact on reputation), consider having differentiators between different strengths – such as different colour for different strengths (of course this will mean more intense product change over cleaning).

Based on root cause identified, consider more exhaustive Product change over procedures (cleaning and line clearance) for product change overs between different strengths of the same generic product.