Medications & Supplements/Prescription Drugs

Prescript Pharmaceuticals, Inc.: Various Prescription Medications Recalled for Incorrect Storage Labeling

Agency Publication Date: May 16, 2018

Summary

Prescript Pharmaceuticals, Inc. has recalled 279 units of several prescription medications, including Clindamycin (an antibiotic), Acetaminophen with Codeine (a pain reliever), and Chlorhexidine liquid (an oral rinse). These medications were packaged with incorrect storage instructions on the labels, stating they should be stored at 59°F to 86°F when the original manufacturer's safe storage range is actually 68°F to 77°F. This error affected 30-count and 28-count containers of Clindamycin, 20-count containers of Acetaminophen with Codeine, and 473ml bottles of Chlorhexidine sold in California.

Risk

If these medications are stored outside of the manufacturer's recommended temperature range due to the incorrect label, the chemical stability and potency of the drugs may be compromised. This could potentially result in the medication being less effective than intended for treating infections or managing pain.

What You Should Do

Check your medication packaging for the following affected products and lot numbers: Clindamycin 150 mg (Lot 0130126), Clindamycin 300 mg (Lot 0130132 Exp 3/31/19), Acetaminophen with Codeine (Lots 0130131 Exp 8/31/20 or 0130130 Exp 12/31/20), or Chlorhexidine 0.12% liquid (Lot 130128 Exp 08/31/20).
Verify if the storage declaration on your bottle incorrectly lists a range of 15°C to 30°C (59°F to 86°F) instead of the correct 20°C to 25°C (68°F to 77°F).
Contact your healthcare provider or pharmacist immediately to determine if your medication is still safe to use or if you need a replacement prescription.
Return any unused or incorrectly labeled product to the pharmacy where it was purchased for a refund.
Contact Prescript Pharmaceuticals, Inc. at their Pleasanton, CA location for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Clindamycin 150 mg capsules, USP (30-count M-Pak container)

Model:

00527-1382-01

0639-30-176

Lot Numbers:

0130126

Product: Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets (20-count M-Pak container)

Model:

13107-059-99

0078-20-2033

Lot Numbers:

0130131 (Exp 8/31/20)

Date Ranges: Exp 8/31/20

Product: Chlorhexidine 0.12% liquid (473 MILLITERS)

Model:

00116-2001-16

1385-38-482

Lot Numbers:

130128 (Exp 08/31/20)

Date Ranges: Exp 08/31/20

Product: Clindamycin 300 mg capsules, USP (28-count M-Pak container)

Model:

00527-1383-01

0784-28-11

Lot Numbers:

0130132 (Exp 3/31/19)

Date Ranges: Exp 3/31/19

Product: Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets (20-count M-Pak container)

Model:

00406-0484-10

0078-20-1834

Lot Numbers:

0130130 (Exp 12/31/20)

Date Ranges: Exp 12/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79961

Status: Resolved

Manufacturer: Prescript Pharmaceuticals, Inc.

Sold By: Prescript Pharmaceuticals, Inc.; Pharmacies in California

Manufactured In: United States

Units Affected: 5 products (50 30-count containers; 1 20-count containers; 24 473-ml bottles; 5 28-count containers; 199 tablets in 20-count containers)

Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication packaging for the following affected products and lot numbers: Clindamycin 150 mg (Lot 0130126), Clindamycin 300 mg (Lot 0130132 Exp 3/31/19), Acetaminophen with Codeine (Lots 0130131 Exp 8/31/20 or 0130130 Exp 12/31/20), or Chlorhexidine 0.12% liquid (Lot 130128 Exp 08/31/20).

Verify if the storage declaration on your bottle incorrectly lists a range of 15°C to 30°C (59°F to 86°F) instead of the correct 20°C to 25°C (68°F to 77°F).

Contact your healthcare provider or pharmacist immediately to determine if your medication is still safe to use or if you need a replacement prescription.

Return any unused or incorrectly labeled product to the pharmacy where it was purchased for a refund.

Contact Prescript Pharmaceuticals, Inc. at their Pleasanton, CA location for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Clindamycin 150 mg capsules, USP (30-count M-Pak container)

Model:

00527-1382-01

0639-30-176

Lot Numbers:

0130126

Product: Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets (20-count M-Pak container)

Model:

13107-059-99

0078-20-2033

Lot Numbers:

0130131 (Exp 8/31/20)

Date Ranges: Exp 8/31/20

Product: Chlorhexidine 0.12% liquid (473 MILLITERS)

Model:

00116-2001-16

1385-38-482

Lot Numbers:

130128 (Exp 08/31/20)

Date Ranges: Exp 08/31/20

Product: Clindamycin 300 mg capsules, USP (28-count M-Pak container)

Model:

00527-1383-01

0784-28-11

Lot Numbers:

0130132 (Exp 3/31/19)

Date Ranges: Exp 3/31/19

Product: Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets (20-count M-Pak container)

Model:

00406-0484-10

0078-20-1834

Lot Numbers:

0130130 (Exp 12/31/20)

Date Ranges: Exp 12/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79961

Status: Resolved

Manufacturer: Prescript Pharmaceuticals, Inc.

Sold By: Prescript Pharmaceuticals, Inc.; Pharmacies in California

Manufactured In: United States

Units Affected: 5 products (50 30-count containers; 1 20-count containers; 24 473-ml bottles; 5 28-count containers; 199 tablets in 20-count containers)

Distributed To: California