post #1 of 1
3/31/04 at 5:06pm
Thread Starter 
The FDA has released the following information.

PRODUCT
a) Bromhist-DM Drops, (Brompheniramine Maleate 1 mg,
Pseudoephedrine Hydrochloride 15 mg, and
Dextromethorphan Hydrobromide 4 mg), Rx Only.
Recall # D-126-4;
Bromhist Pediatric Drops, (Brompheniramine Maleate 1 mg,
Pseudoephedrine Hydrochloride 15 mg. Rx Only.
Recall # D-127-4.

CODE
a) and b) Lot number/Expiration date: P03106 (1/2006).

RECALLING FIRM/MANUFACTURER
Great Southern Laboratories, Houston, TX, by telephone and letter on March 4, 2004. Firm initiated recall is ongoing.

REASON
Mislabeling: Bromhist-DM drops packaged in Bromhist Pediatric Drops carton. Carton is not labeled to contain Dextromethorphan Hydrobrimide 4mg/mL.

VOLUME OF PRODUCT IN COMMERCE
1,221 units.

DISTRIBUTION
Nationwide.
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