Medications & Supplements/Prescription Drugs

American Health Packaging: Pramipexole Dihydrochloride Tablets Recalled for Possible Cross-Contamination

Agency Publication Date: June 28, 2019

Summary

American Health Packaging is recalling 35,133 cartons of Pramipexole Dihydrochloride, a prescription medication used to treat Parkinson's disease and Restless Legs Syndrome. This recall was initiated because of a failure in cleaning procedures that could lead to cross-contamination between different drug products. This voluntary recall affects multiple strengths of the medication, including 0.125 mg, 0.25 mg, 0.5 mg, and 1.0 mg tablets distributed nationwide across the United States.

Risk

A failure in cleaning equipment between production batches may have allowed different drug products to mix, posing a risk that consumers could inadvertently ingest an unintended medication or contaminant. This could lead to unexpected side effects or reduced effectiveness of the prescribed treatment.

What You Should Do

Check your medication packaging for 'Pramipexole Dihydrochloride Tablets' in the following strengths: 0.125 mg (NDC 68084-793-25), 0.25 mg (NDC 68084-440-01), 0.5 mg (NDC 68084-974-25), or 1.0 mg (NDC 68084-982-25).
Verify if your specific lot number and expiration date are affected: for 0.125 mg (Lot 179049 exp 12/31/2019, Lot 182571 exp 8/31/2020); for 0.25 mg (Lot 172669 exp 05/31/2019, Lots 175872 or 177086 exp 09/30/2019, Lot 179047 exp 12/31/2019, Lot 182584 exp 07/31/2020).
Check 0.5 mg tablets for: Lots 175820 or 176569 (exp 09/30/2019), Lots 177866, 179627A, or 179627B (exp 12/31/2019), or Lot 181627 (exp 06/30/2020).
Check 1.0 mg tablets for: Lot 176179 (exp 05/31/2019), Lot 176616 (exp 07/31/2019), Lot 178562 (exp 09/30/2019), Lot 179947 (exp 12/31/2019), Lot 182048 (exp 04/30/2020), Lot 183136 (exp 06/30/2020), or Lot 184217 (exp 08/31/2020).
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.
Return any unused product to the pharmacy where it was purchased for a refund and contact American Health Packaging for further instructions.
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 for unused product.

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

Affected Products

Product: Pramipexole Dihydrochloride Tablets, 0.125 mg (30 Tablets)

Model:

NDC Blister Card: 68084-793-95

NDC Carton: 68084-793-25

Recall #: D-1431-2019

Lot Numbers:

179049 (Exp 12/31/2019)

182571 (Exp 8/31/2020)

Product: Pramipexole Dihydrochloride Tablets, 0.25 mg (100 Tablets)

Model:

NDC Blister Card: 68084-440-11

NDC Carton: 68084-440-01

Recall #: D-1432-2019

Lot Numbers:

172669 (Exp 05/31/2019)

175872 (Exp 09/30/2019)

177086 (Exp 09/30/2019)

179047 (Exp 12/31/2019)

182584 (Exp 07/31/2020)

Product: Pramipexole Dihydrochloride Tablets, 0.5 mg (30 Tablets)

Model:

NDC Blister Card: 68084-974-95

NDC Carton: 68084-974-25

Recall #: D-1433-2019

Lot Numbers:

175820 (Exp 09/30/2019)

176569 (Exp 09/30/2019)

177866 (Exp 12/31/2019)

179627A (Exp 12/31/2019)

179627B (Exp 12/31/2019)

181627 (Exp 06/30/2020)

Product: Pramipexole Dihydrochloride Tablets, 1.0 mg (30 Tablets)

Model:

NDC Blister Card: 68084-982-95

NDC Carton: 68084-982-25

Recall #: D-1434-2019

Lot Numbers:

176179 (Exp 05/31/2019)

176616 (Exp 07/31/2019)

178562 (Exp 09/30/2019)

179947 (Exp 12/31/2019)

182048 (Exp 04/30/2020)

183136 (Exp 06/30/2020)

184217 (Exp 08/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82863

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (3,015 cartons; 16,698 cartons; 8,777 cartons; 6,643 cartons)

Distributed To: Nationwide

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 'Pramipexole Dihydrochloride Tablets' in the following strengths: 0.125 mg (NDC 68084-793-25), 0.25 mg (NDC 68084-440-01), 0.5 mg (NDC 68084-974-25), or 1.0 mg (NDC 68084-982-25).

Verify if your specific lot number and expiration date are affected: for 0.125 mg (Lot 179049 exp 12/31/2019, Lot 182571 exp 8/31/2020); for 0.25 mg (Lot 172669 exp 05/31/2019, Lots 175872 or 177086 exp 09/30/2019, Lot 179047 exp 12/31/2019, Lot 182584 exp 07/31/2020).

Check 0.5 mg tablets for: Lots 175820 or 176569 (exp 09/30/2019), Lots 177866, 179627A, or 179627B (exp 12/31/2019), or Lot 181627 (exp 06/30/2020).

Check 1.0 mg tablets for: Lot 176179 (exp 05/31/2019), Lot 176616 (exp 07/31/2019), Lot 178562 (exp 09/30/2019), Lot 179947 (exp 12/31/2019), Lot 182048 (exp 04/30/2020), Lot 183136 (exp 06/30/2020), or Lot 184217 (exp 08/31/2020).

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.

Return any unused product to the pharmacy where it was purchased for a refund and contact American Health Packaging for further instructions.

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: Pramipexole Dihydrochloride Tablets, 0.125 mg (30 Tablets)

Model:

NDC Blister Card: 68084-793-95

NDC Carton: 68084-793-25

Recall #: D-1431-2019

Lot Numbers:

179049 (Exp 12/31/2019)

182571 (Exp 8/31/2020)

Product: Pramipexole Dihydrochloride Tablets, 0.25 mg (100 Tablets)

Model:

NDC Blister Card: 68084-440-11

NDC Carton: 68084-440-01

Recall #: D-1432-2019

Lot Numbers:

172669 (Exp 05/31/2019)

175872 (Exp 09/30/2019)

177086 (Exp 09/30/2019)

179047 (Exp 12/31/2019)

182584 (Exp 07/31/2020)

Product: Pramipexole Dihydrochloride Tablets, 0.5 mg (30 Tablets)

Model:

NDC Blister Card: 68084-974-95

NDC Carton: 68084-974-25

Recall #: D-1433-2019

Lot Numbers:

175820 (Exp 09/30/2019)

176569 (Exp 09/30/2019)

177866 (Exp 12/31/2019)

179627A (Exp 12/31/2019)

179627B (Exp 12/31/2019)

181627 (Exp 06/30/2020)

Product: Pramipexole Dihydrochloride Tablets, 1.0 mg (30 Tablets)

Model:

NDC Blister Card: 68084-982-95

NDC Carton: 68084-982-25

Recall #: D-1434-2019

Lot Numbers:

176179 (Exp 05/31/2019)

176616 (Exp 07/31/2019)

178562 (Exp 09/30/2019)

179947 (Exp 12/31/2019)

182048 (Exp 04/30/2020)

183136 (Exp 06/30/2020)

184217 (Exp 08/31/2020)