Recalls / Class III

Class IIID-66207-001

Product

GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716

Affected lot / code info

1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).

Why it was recalled

Subpotent; phenylephrine HCl

Recalling firm

Firm

Hi-Tech Pharmacal Co., Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

369 Bayview Ave, N/A, Amityville, New York 11701-2801

Distribution

Quantity

50,848 bottles (total for 3 lots)

Distribution pattern

Puerto Rico

Timeline

Recall initiated

2013-09-04

FDA classified

2013-10-22

Posted by FDA

2013-10-30

Terminated

2015-04-29

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-66207-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.