Prempro, Other Pfizer Drugs Recalled Over Quality Issues

Quality control issues and problems with glass particle contamination have led to a recall for three different Pfizer drugs, including the hormone replacement therapy (HRT) Prempro.  

Last month, Pfizer announced a recall of five lots of Prempro, 11 lots of the antibiotic Cleocin Phosphate, and two lots of the heart rhythm disorder drug Norpace. The recalls were conducted at the pharmacy level.

The Prempro recall was issued because of substandard potency, which was discovered during routine testing. The company believes that very few of the affected vials are on pharmacy shelves, since the drug was due to expire at the end of June.

The Cleocin recall, also sold under the brand name Dalacin, was issued after it was discovered that vials may be contaminated with glass fragments. The recall came after reflective flakes were spotted, which could pose a risk of mild inflammation or even serious and life-threatening injuries, such as pulmonary embolism.

The recall affects about 898,900 vials of Cleocin Phosphate in a variety of sizes with NDC numbers 0009-3124-03 and 0009-3447-03. The drugs were sold by Pfizer subsidiary Pharmacia & Upjohn LLC.

The Norpace recall was issued after one of the lots failed to meet standards for dissolution during stability testing. The other lot affected by the recall showed signs that it would fail those standards as well before its expiration date. The recall affects Norpace CR extended-release capsules USP 150 mg, sold in 100 and 500-count bottles. The 100-count bottles have NDC number 0025-2742-31 and lot number C120138. The 500-count bottles have NDC number 0025-2742-51 and lot number C120137. Both have an expiration date of 07/13.