Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Reason Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Reason Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Reason Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
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