FDA orders recall of 'Loviscol' cough syrup batches

Published August 20, 2012 10:53am

The Food and Drug Administration has ordered the recall of batches of cough medicine over what it said was an incorrect declaration of the formulation in the products' carton and bottle labels.

In its Advisory 2012-007, the FDA ordered Pfizer Consumer Healthcare to recall some batches of Carbocisteine (Loviscol) 50 mg/ml syrup (oral drops).

"Continuous distribution of the said product present(s) health risk to the consuming sector of the public, especially children," FDA OIC Nicolas Lutero III said.

In the advisory, dated Aug. 14, the FDA said the batches to be recalled include:

11LID6, with Aug. 14 expiration date, 15 ml pack size
11LID8, with Oct. 14 expiration date, 15 ml pack size
11LID9, with Oct. 14 expiration date, 15 ml pack size
12LID1A, with Dec. 14 expiration date, 15 ml pack size
12LID1B (samples only), with Dec. 14 expiration date, 5 ml pack size
12LID2, with Jan. 15 expiration date, 15 ml pack size

The FDA cited an "incorrect concentration declaration of the claim reflected in the formulation for both the carton and bottle labels of the product Carbocisteine (Loviscol) 50 mg/ml Syrup (oral drops)."

"(A)ny establishment carrying the above-identified lots of the product are advised to discontinue selling the same and immediately return them to Pfizer for proper disposition," Lutero said. Pfizer identifies root cause In a media statement released on Thursday, Pfizer, Inc.'s Consumer Healthcare Business said "all stocks of Carbocisteine (Loviscol) 50 mg/mL Syrup (Oral drops) currently in the market will be recalled."

The company stressed, though, that the quality of the medicine is still the same.

"There is NO issue with the quality of the medicine itself or the main dosage instructions. This recall does NOT affect any other Loviscol variants (i.e., Loviscol Syrup, Loviscol Capsule)," the statement read.

Pfizer added it has traced the problem.

"The company has identified the root cause of the labeling consistency and has taken immediate corrective measures," it said.

"All future products will carry the correct concentration declaration. The Company is working diligently to ensure the continuity of product supply with the correct labelling in retail outlets at the soonest possible time," it added.

Pfizer said the public may contact the Pfizer Healthline for inquiries: (02) 671-1000; 1800-10-6711000 (PLDT provincial toll-free); 1800-3-6711000 (Digitel provincial toll-free); fax: (02) 6722000; 1800-10-6722000 (PLDT provincial toll-free), or via SMS at 0918-8Pfizer (0918-8734937). — With a report from Patricia Denise Chiu/ELR/KG, GMA News

Tags: productrecall, loviscolcoughsyrup, pfizer, foodanddrugadministration